Treat ment of
Chlamydia t rachomat is
WHO Library Cat aloguing- in- Publicat ion Dat a
WHO guidelines for t he t reat ment of Chlamydia t rachomat is.
CONTENTS
Acknowledgement s iii
Overview of t he guidelines for t he prevent ion, t reat ment and management of STIs 6
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Approach to t he revision of STI guidelines 8
References 9
2. Met hods 12
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2.2 Quest ions and outcomes 12
2.3 Reviews of t he evidence 12
2.4 Making recommendat ions 13
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3. Disseminat ion, updat ing and implement at ion of t he guidelines 15
3.1 Disseminat ion 15
3.2 Updat ing t he STI guidelines and user feedback 15
3.3 Implement at ion of t he WHO guidelines for t he t reat ment of C. t rachomat is 15
Adapt at ion, implement at ion and monitoring 15
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4. Recommendat ions for t reat ment of chlamydial infect ions 17
4.1 Uncomplicated genit al chlamydia 17
Recommendat ion 1 17
4.2 Anorect al chlamydial infect ion 18
Recommendat ion 2 18
4.3 Chlamydial infect ion in pregnant women 19
Recommendat ion 3a 19
Recommendat ion 3b 19
Recommendat ion 3c 19
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6 WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS
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Recommendat ion 7 21
References 22
ACKNOWLEDGEMENTS
The Depart ment of Reproduct ive Healt h and Research Members: <DZ 6D[ $GX 6DUNRGLH $QGUHZ $PDWR
DW WKH :RUOG +HDOWK 2UJDQL]DWLRQ :+2 ZRXOG OLNH WR Gail Bolan, John Changalucha, Xiang- Sheng Chen,
t hank t he members of t he STI Guideline Development Harrel Chesson, Craig Cohen, Francisco Garcia,
Group for t heir consistent availabilit y and commit ment Suzanne Garland, Sarah Hawkes, Mary Higgins,
to making t hese guidelines possible. The Depart ment .LQJ +ROPHV -HUH\ .ODXVQHU 'DYLG /HZLV 1LFROD /RZ
is also grateful to t he STI External Review Group for David Mabey, Angelica Espinosa Miranda, Nelly Mugo,
peer reviewing t hese guidelines, and appreciates Saiqa Mullick, Francis Ndowa, Joel Palefsky,
t he cont ribut ion of t he WHO Steering Commit tee. .HLWK 5DGFOLH 8OXJEHN 6DELURY -XGLWK 6WHSKHQVRQ
The names of t he members of each group are list ed Richard Steen, Magnus Unemo, Bea Vuylsteke,
below, wit h full det ails provided in Annex A. Anna Wald, Thomas Wong and Kimberly A. Workowski
Special t hanks to Dr Nancy Sant esso, t he guideline STI GDG working group for chlamydia:
met hodologist who also led t he systemat ic review Andrew Amato, Harrell Chesson, Craig Cohen,
SURFHVV IRU KHU KDUG ZRUN DQG UP FRPPLWPHQW RI Pat ricia Garcia, Nicola Low, David Mabey, Angelica
t he guideline development process. We also t hank 0LUDQGD )UDQFLV 1GRZD .HLWK 5DGFOLH -XGLWK
t he members of t he Systemat ic Review Team from Stephenson, Magnus Unemo, Bea Vuylsteke and
McMaster Universit y. Judit h Wasserheit
We appreciate t he overall support of t he WHO STI Ext ernal Review Group: Lait h Abu- Raddad,
Guideline Review Commit tee Secret ariat during t he Adele Benaken- Schwart z, Mircea Bet iu, Anupong
guideline development process, wit h grateful t hanks Chit warakorn, Anjana Das, Carolyn Deal,
to Dr Susan Norris. Margaret Gale- Rowe, William M. Geisler, Amina
El Ket t ani, Mizan Kiros, Ahmed Lat if, Philippe
We t hank Theresa Ryle for t he administ rat ive
Mayaud, David McCart ney, Ali M. Mir, Nuriye Ort ayli,
VXSSRUW DQG &RPPXQLFDWLRQV IRU DVVLVWDQFH
Khant anouvieng Sayabount havong and
wit h t he guideline design and layout . This guideline
Aman Kumar Singh
document was edited by Ms Jane Pat ten, of Green Ink,
United Kingdom. WHO St eering Commit t ee:
Dr Teodora Wi led t he guideline development process :+2 UHJLRQDO RFHV Massimo Ghidinelli, Hamida
and Dr Nat halie Broutet co- led t he process under Khat t abi, Lali Khot enashvili, Ornella Lincet to Ying- Ru Lo,
t he supervision of Dr James Kiarie and leadership of Frank Lule and Razia Pendse
Dr Ian Askew. Lee Sharkey provided support during
WHO headquart ers: Moazzam Ali, Avni Amin, Rachel
t he guideline development process.
Baggaley, Venkat raman Chandra- Mouli, Jane Ferguson,
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FUNDING Sami Got t lieb, Silvio Paolo Mariot t i, Frances McConville,
Lori Newman, Annet te Mwansa Nkowane, Anit a Sands,
The preparat ion and print ing of t he guidelines were
Igor Toskin and Marco Vitoria
funded exclusively by t he UNDP/ UNFPA/ UNICEF/
WHO/ World Bank Special Programme of Research, WHO STI Secret ariat : Ian Askew, Teodora Elvira Wi
Development and Research Training in Human OHDG GHYHORSPHQW RI WKH JXLGHOLQHV 1DWKDOLH %URXWHW
5HSURGXFWLRQ +53 1R H[WHUQDO VRXUFH RI IXQGLQJ FR OHDG GHYHORSPHQW RI WKH JXLGHOLQHV -DPHV .LDULH
was solicited or ut ilized. and Lee Sharkey
Syst emat ic Review Team: 1DQF\ 6DQWHVVR OHDG
CONTRIBUTORS TO WHO GUIDELINES FORTHE Housne Begum, Janna- Lina Kert h, Gian Paolo Morgano,
TREATMENT OF CHLAMYDIA TRACHOMATIS Krist ie Poole, Nicole Schwab, Mat t hew Vent resca,
<XDQ =KDQJ DQG $QGUHZ =LNLF PHPEHUV
STI Guideline Development Group (GDG):
Met hodologist : Nancy Sant esso.
Chairpersons: Judit h Wasserheit , Holger Schnemann
and Pat ricia Garcia
8 WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS
HRP UNDP/ UNFPA/ UNICEF/ WHO/ World Bank Special Programme of Research,
Development and Research Training in Human Reproduct ion
EXECUTIVE SUMMARY
Table 1. Summary of recommendat ions for t reat ment of chlamydial infect ions
A WHO STI expert consult at ion recommended 1HZ UDSLG SRLQW RI FDUH GLDJQRVWLF WHVWV 32&7V DUH
XSGDWLQJ WKH :+2 JXLGHOLQHV IRU WKH UVW DQG changing STI management . Rapid syphilis diagnost ic
second- line t reat ment s for C. t rachomat is, increasing test s are now widely available, making syphilis screening
WKH GRVDJH RI FHIWULD[RQH WR PJ IRU WUHDWPHQW more widely accessible and allowing for earlier init iat ion
of N. gonorrhoeae wit h cont inued monitoring of RI WUHDWPHQW IRU WKRVH ZKR WHVW SRVLWLYH (RUWV DUH
ant imicrobial suscept ibilit y, and considerat ion of under way to develop POCTs for ot her STIs t hat will
ZKHWKHU D]LWKURP\FLQ J VLQJOH GRVH VKRXOG EH augment syndromic management of symptomat ic
recommended in early syphilis (16). cases and increase t he abilit y to ident ify asymptomat ic
infect ions (12). Updated guidelines are needed t hat
The epidemiology of STIs is changing, wit h viral
incorporate rapid test s into syndromic management
pat hogens becoming more prevalent t han bacterial
of STIs and provide algorit hms for test ing and
HWLRORJLHV IRU VRPH FRQGLWLRQV WKLV PHDQV WKDW XSGDWHG
screening (16).
informat ion is required to inform locally appropriate
prevent ion and t reat ment st rategies. An increasing Alt hough recent technological advances in diagnost ics,
proport ion of genit al ulcers are now due to viral WKHUDSHXWLFV YDFFLQHV DQG EDUULHU PHWKRGV RHU EHWWHU
infect ions as previously common bacterial infect ions, opportunit ies for t he prevent ion and care of STIs, access
such as chancroid, approach eliminat ion in many to t hese technologies is st ill limited, part icularly in areas
count ries (16, 17). As recommended during t he STI where t he burden of infect ion is highest . For opt imal
expert consult at ion, t reat ment guidelines for genit al HHFWLYHQHVV JOREDO JXLGHOLQHV IRU WKH PDQDJHPHQW
XOFHU GLVHDVH *8' VKRXOG EH XSGDWHG WR LQFOXGH +69 of STIs need to include approaches for set t ings wit h
t reat ment and a longer t reat ment durat ion for HSV-2 limited access to modern technologies, as well as for
should be explored. In addit ion, suppressive t herapy set t ings in which t hese technologies are available.
for HSV-2 should be considered in areas wit h high HIV
It is st rongly recommended t hat count ries t ake
prevalence (16). The chronic, lifelong nature of viral
updated global guidance into account as t hey est ablish
infect ions also requires t hat renewed at tent ion be paid
st andardized nat ional protocols, adapt ing t his guidance
WR GHYHORSLQJ HHFWLYH SUHYHQWLRQ VWUDWHJLHV LQFOXGLQJ
to t he local epidemiological sit uat ion and ant imicrobial
expanding accessibilit y to available vaccines for HPV
suscept ibilit y dat a. St andardizat ion ensures t hat all
and development of new vaccines for HSV-2.
pat ient s receive adequate t reat ment at every level
,Q WKH :+2 JXLGHOLQHV D V\QGURPLF DSSURDFK of healt h- care services, opt imizes t he t raining and
was recommended for t he management of STIs. supervision of healt h- care providers and facilit ates
The approach guides t he diagnosis of STIs based on procurement of medicines. It is recommended t hat
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easily recognized signs and indicates t reat ment for STIs be developed in close consult at ion wit h local STI,
t he majorit y of organisms t hat may be responsible public healt h and laboratory expert s.
for producing t he syndrome. The syndromic
management algorit hms need to be updated in
response to t he changing sit uat ion. In addit ion to
changes to t he GUD algorit hm, ot her syndromes
need to be re- evaluated, part icularly vaginal discharge.
The approach to syndromes for key populat ions
also needs to be updated. For example, addit ion of
a syndromic management algorit hm for anorect al
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sex workers is urgent ly needed since a subst ant ial
number of t hese infect ions go unrecognized and
unt reated in t he absence of guidelines (16).
8 WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS
Phase 1 will focus on t reat ment recommendat ions In addit ion, guidelines for t he STI syndromic approach
IRU VSHFLF 67,V DV ZHOO DV RWKHU LPSRUWDQW DQG XUJHQW and a clinical management package will be developed
STI issues. Recommendat ions for t he t reat ment of later in Phase 1. Phase 2 will focus on guidelines for STI
VSHFLF LQIHFWLRQV ZLOO EH GHYHORSHG DQG SXEOLVKHG prevent ion. The independent Phase 1 and 2 modules
as independent modules: will later be consolidated into one document and
published as comprehensive WHO guidelines on STI
Chlamydia t rachomatis FKODP\GLD
case management . Phase 3 will address t reat ment of
Neisseria gonorrhoeae JRQRUUKRHD addit ional infect ions, including Trichomonas vaginalis
+69 JHQLWDO KHUSHV WULFKRPRQLDVLV EDFWHULDO YDJLQRVLV &DQGLGD DOELFDQV
Treponema pallidum V\SKLOLV FDQGLGLDVLV +HPRSKLOXV GXFUH\L FKDQFURLG .OHEVLHOOD
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Syphilis screening and t reat ment of pregnant women.
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SXELF OLFH 3KDVH ZLOO SURYLGH JXLGDQFH RQ ODERUDWRU\
diagnosis and screening of STIs.
WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 9
REFERENCES
1. Newman L, Rowley J, Vander Hoorn S, Wijesooriya NS, Unemo M, Low N et al. Global est imat es of t he
SUHYDOHQFH DQG LQFLGHQFH RI IRXU FXUDEOH VH[XDOO\ WUDQVPLWWHG LQIHFWLRQV LQ EDVHG RQ V\VWHPDWLF
UHYLHZ DQG JOREDO UHSRUWLQJ 3/R6 2QH H GRL MRXUQDO SRQH
2. Looker KJ, Magaret AS, Turner KME, Vickerman P, Got t lieb SL, Newman LM. Global est imat es of
SUHYDOHQW DQG LQFLGHQW KHUSHV VLPSOH[ YLUXV W\SH LQIHFWLRQV LQ 3/R6 2QH H
GRL MRXUQDO SRQH
'H 6DQMRV 6 'LD] 0 &DVWHOOVDJX ; &OLRUG * %UXQL / 0XR] 1 %RVFK ); :RUOGZLGH SUHYDOHQFH
and genot ype dist ribut ion of cervical human papillomavirus DNA in women wit h normal cyt ology:
D PHWD DQDO\VLV /DQFHW ,QIHFW 'LV
4. Wijesooriya NS, Rochat RW, Kamb ML, Turlapat i P, Brout et N, Newman L. Declines in mat ernal and
FRQJHQLWDO V\SKLOLV IURP WR SURJUHVV WRZDUGV HOLPLQDWLRQ RI PRWKHU WR FKLOG WUDQVPLVVLRQ
RI V\SKLOLV /DQFHW *OREDO +HDOWK LQ SUHVV
5. Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C et al. Disabilit y- adjust ed life
\HDUV '$/<V IRU GLVHDVHV DQG LQMXULHV LQ UHJLRQV D V\VWHPDWLF DQDO\VLV IRU
WKH *OREDO %XUGHQ RI 'LVHDVH 6WXG\ /DQFHW GRL 6
*RWWOLHE 6/ /RZ 1 1HZPDQ /0 %RODQ * .DPE 0 %URXWHW 1 7RZDUG JOREDO SUHYHQWLRQ RI VH[XDOO\
WUDQVPLWWHG LQIHFWLRQV 67,V WKH QHHG IRU 67, YDFFLQHV 9DFFLQH GRL M
YDFFLQH
-RKQVRQ /) /HZLV '$ 7KH HHFW RI JHQLWDO WUDFW LQIHFWLRQV RQ +,9 VKHGGLQJ LQ WKH JHQLWDO
WUDFW D V\VWHPDWLF UHYLHZ DQG PHWD DQDO\VLV 6H[ 7UDQVP 'LV GRL
2/4 E H G
11. Cohen MS. Classical sexually t ransmit t ed diseases drive t he spread of HIV-1: back t o t he fut ure.
- ,QIHFW 'LV GRL LQIGLV MLV
12. Progress report of t he implement at ion of t he global st rat egy for prevent ion and cont rol of sexually
WUDQVPLWWHG LQIHFWLRQV *HQHYD :RUOG +HDOWK 2UJDQL]DWLRQ KWWS DSSV ZKR LQW
LULV ELWVWUHDP BHQJ SGI DFFHVVHG 0D\
13. Ndowa FJ, Ison CA, Lust i- Narasimhan M. Gonococcal ant imicrobial resist ance: t he implicat ions for
SXEOLF KHDOWK FRQWURO 6H[ 7UDQVP ,QIHFW 6XSSO LY GRL VH[WUDQV
14. Got t lieb SL, Low N, Newman LM, Bolan G, Kamb M, Brout et N. Toward global prevent ion of sexually
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YDFFLQH
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PDQDJHPHQW RI VH[XDOO\ WUDQVPLWWHG LQIHFWLRQV *HQHYD :RUOG +HDOWK 2UJDQL]DWLRQ :+2
5+5 KWWS DSSV ZKR LQW LULV ELWVWUHDP :+2B5+5B BHQJ SGI
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CLINICAL PRESENTATION
Genit al infect ions due to C. t rachomatis are
DV\PSWRPDWLF LQ DSSUR[LPDWHO\ RI ZRPHQ DQG
RI PHQ (2). Sympt oms of uncomplicated chlamydial
infect ion in women include abnormal vaginal discharge,
dysuria, and post- coit al and intermenst rual bleeding.
Common clinical signs on speculum examinat ion
include cervical friabilit y and discharge. Sympt omat ic
men usually present wit h uret hral discharge and
dysuria, somet imes accompanied by test icular pain.
If left unt reated, most genit al infect ions will resolve
spont aneously wit h no sequelae but t hey may result in
severe complicat ions, mainly in young women. Infect ion
can ascend to t he upper reproduct ive t ract and can
FDXVH SHOYLF LQDPPDWRU\ GLVHDVH HFWRSLF SUHJQDQF\
salpingit is and tubal factor infert ilit y in women (3) and
epididymit is in men (4). The risk of complicat ions may
increase wit h repeated infect ion.
Infect ions at non- genit al sit es are common. Rect al
infect ion may manifest as a rect al discharge, rect al
pain or blood in t he stools, but is asymptomat ic in
most cases. Oropharyngeal infect ions can manifest as
pharyngit is and mild sore t hroat , but symptoms are rare.
Chlamydial infect ion in pregnancy is associat ed wit h
1.1 EPIDEMIOLOGY, BURDEN AND CLINICAL preterm birt h and low birt h weight . Infant s of mot hers
CONSIDERATIONS wit h chlamydia can be infected at delivery, result ing in
Chlamydial infect ion, caused by Chlamydia t rachomat is, neonat al conjunct ivit is and/ or nasopharyngeal infect ion
is t he most common bacterial sexually t ransmit ted (3). Sympt oms of opht halmia include ocular discharge
and swollen eyelids. In newborns, nasopharyngeal
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and economic cost worldwide. The World Healt h infect ion can lead to pneumonit is.
2UJDQL]DWLRQ :+2 HVWLPDWHV WKDW LQ LGV, caused by a more invasive serovar of
million new cases of chlamydia occurred among adult s C. t rachomat is DHFWV WKH VXEPXFRVDO FRQQHFWLYH
and adolescent s aged 1549 years worldwide, wit h a t issue and can spread to regional lymph nodes.
JOREDO LQFLGHQFH UDWH RI SHU IHPDOHV DQG It commonly present s as a unilateral, tender
SHU PDOHV 7KH HVWLPDWHG PLOOLRQ SUHYDOHQW inguinal or femoral lymph node and a genit al ulcer
cases of chlamydia result in an overall prevalence of or papule (5). Anorect al exposure may result in
4.2% for females and 2.7% for males, wit h t he highest proct it is, rect al discharge, pain, const ipat ion or
prevalence in t he WHO Region of t he Americas and t he tenesmus. Left unt reated, LGV can lead to rect al
:+2 :HVWHUQ 3DFLF 5HJLRQ (1). In many count ries, t he VWXOD RU VWULFWXUH
incidence of chlamydia is highest among adolescent
girls aged 1519 years, followed by young women aged
\HDUV 7KH WKUHH ELRYDUV RI C. t rachomat is, each
consist ing of several serovars or genot ypes, cause
genit al infect ions, lymphogranuloma venereum (LGV:
D JHQLWDO XOFHU GLVHDVH >*8'@ WKDW DHFWV O\PSKRLG
WLVVXH DQG WUDFKRPD H\H LQIHFWLRQ
WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 11
1.3 OBJECTIVES
The object ives of t hese guidelines are:
to provide evidence- based guidance on t reat ment
of infect ion wit h C. t rachomat is DQG
to support count ries to update t heir nat ional
guidelines for t reat ment of chlamydial infect ion.
12 WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS
The qualit y/ cert aint y of t he evidence was assessed of t he recommendat ions. Following t he meet ing, t he
at four levels: UHFRPPHQGDWLRQV ZHUH QDOL]HG YLD WHOHFRQIHUHQFH
DQG QDO DSSURYDO ZDV REWDLQHG IURP DOO *'* PHPEHUV
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elect ronically. These guidelines were subsequent ly
FORVH WR WKDW RI WKH HVWLPDWH RI WKH HHFW
writ ten up in full and t hen peer reviewed. The External
0RGHUDWH :H DUH PRGHUDWHO\ FRQGHQW LQ WKH HHFW Review Group approved t he met hods and agreed wit h
HVWLPDWH WKH WUXH HHFW LV OLNHO\ WR EH FORVH WR WKH t he recommendat ions made by t he GDG (members
HVWLPDWH RI WKH HHFW EXW WKHUH LV D SRVVLELOLW\ WKDW DUH OLVWHG LQ $QQH[ $
LW LV VXEVWDQWLDOO\ GLHUHQW
According to t he GRADEapproach, t he st rengt h
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of each recommendat ion was rated as eit her
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st rong or condit ional. St rong recommendat ions are
HVWLPDWH RI WKH HHFW
presented using t he wording The WHO STI guideline
9HU\ ORZ :H KDYH YHU\ OLWWOH FRQGHQFH LQ WKH HHFW recommends, while condit ional recommendat ions
HVWLPDWH WKH WUXH HHFW LV OLNHO\ WR EH VXEVWDQWLDOO\ are worded as The WHO STI guideline suggest s
GLHUHQW IURP WKH HVWLPDWH RI HHFW t hroughout t he guidelines. The implicat ions of t he
In addit ion, t he direct cost s of medicines were est imated GLHULQJ VWUHQJWKV RI UHFRPPHQGDWLRQV IRU SDWLHQWV
XVLQJ WKH 0DQDJHPHQW 6FLHQFHV IRU +HDOWK 06+ clinicians and policy- makers are explained in det ail
Internat ional drug price indicator guide (10). References in Table 3.
for all t he reviewed evidence are list ed in Annex C.
All evidence was summarized in GRADEevidence
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Table 3. Implicat ions of st rong and condit ional recommendat ions using t he GRADEapproach
For furt her guidance on adapt at ion, implement at ion In order to est imate t he quant it y of medicines needed,
and monitoring of nat ional guidelines please refer to it will be necessary to review t he medicines t hat are
,QWURGXFLQJ :+2V UHSURGXFWLYH KHDOWK JXLGHOLQHV recommended for t reat ment , t heir unit prices, t he
and tools into nat ional programmes: principles and quant it y required per t reat ment and t he epidemiological
processes of adapt at ion and implement at ion (12). informat ion on t he prevalence of infect ion. One can
est imate medicine needs by mult iplying t he est imated
In adapt ing t he guidelines for nat ional use,
number of cases by t he tot al quant it y of medicine
UHFRPPHQGHG WUHDWPHQWV VKRXOG KDYH DQ HFDF\
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of at least 95%. The criteria to be considered for
can be derived from healt h cent res providing care but
t he select ion of medicines are list ed in Box 1.
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Recommended medicines should meet as many of t he
criteria as possible, t aking into account local availabilit y, Budget ing for medicines is crit ical. If t he nat ional
HFDF\ URXWH DQG IUHTXHQF\ RI DGPLQLVWUDWLRQ minist ry of healt h does not provide medicines for free
DQG WKH SDWLHQW FDQQRW DRUG WR EX\ WKH PHGLFLQHV
t hen t here will essent ially be no possibilit y of
BOX 1. CRITERIA FORTHE SELECTION OF curt ailing t he spread of infect ion and t he occurrence
MEDICINES FORTHE TREATMENT OF STIS of complicat ions. At t he nat ional level it is import ant
+LJK HFDF\ DW OHDVW FXUH UDWH WKDW GHFLVLRQ PDNHUV SROLWLFLDQV DQG VFDO FRQWUROOHUV
underst and t he need to subsidize STI medicines.
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Low- cost STI medicines can be obt ained t hrough
Low cost internat ional vendors of generic product s, non-
Low toxicit y levels SURW RUJDQL]DWLRQV ZLWK SURFXUHPHQW VFKHPHV VXFK
Organism resist ance unlikely to develop as UNICEF, UNFPA and UNHCR, and t hrough joint
or likely to be delayed medicine procurement schemes. By way of such
schemes, nat ional programmes can join ot her nat ional
Single dose
programmes to joint ly procure medicines, t hus reducing
Oral administ rat ion t he overall cost s by sharing t he overhead cost s and
Not cont raindicated for pregnant or t aking advant age of discount s for purchasing in bulk.
lact at ing women Placing STI medicines on nat ional list s of essent ial
medicines increases t he likelihood of achieving a
Appropriate medicines should be included in t he
supply of t hese medicines at low cost .
nat ional essent ial medicines list s. When select ing
medicines, considerat ion should be given to t he
competencies and experience of healt h- care
providers.
t here are no dat a for adverse event s related to Condit ional recommendation, low qualit y evidence
very high doses. Higher doses of any tet racycline
Remarks: This recommendat ion applies to people
compared wit h lower doses may lead to more cures
wit h known anorect al infect ion and to people wit h
but will probably also lead to more adverse event s.
suspected anorect al infect ions wit h genit al co-
Tet racyclines compared wit h quinolones may lead
infect ion. Clinicians should ask men, women and key
to fewer cures but also slight ly fewer adverse event s.
populat ions (e.g. men who have sex wit h men [MSM],
Eryt hromycin compared wit h quinolones may lead
WUDQVJHQGHU SHUVRQV DQG IHPDOH VH[ ZRUNHUV DERXW
to fewer cures and more adverse event s.
anal sex and t reat accordingly. Doxycycline should
There is no evidence relat ing to pat ient values and not be used in pregnant women because of adverse
preferences but t he Guideline Development Group HHFWV VHH UHFRPPHQGDWLRQV D F
*'* DJUHHG WKDW WKHUH LV SUREDEO\ QR YDULDELOLW\ LQ
Research implicat ions: The global incidence of
t he values people place on t he outcomes. Research
chlamydial anorect al infect ions should be determined.
related to ot her condit ions indicates t hat adherence
0RUH UHVHDUFK LV QHFHVVDU\ RQ WKH HHFWV RI WUHDWPHQWV
may be improved wit h simpler medicat ion regimens.
used for anorect al infect ions, part icularly azit hromycin,
The GDG t herefore agreed t hat azit hromycin may be
which is current ly not on t he WHO essent ial medicines
more accept able to pat ient s since it is a single dose
list for anorect al chlamydial infect ions (13) (HFWV
regimen (a majorit y of t he GDG members considered
should be assessed in bot h men and women, and in
single- dose regimens to be preferable for pat ient
key populat ions (e.g. MSM, t ransgender persons and
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lit t le to no evidence for equit y issues and feasibilit y.
Resist ance in ot her infect ions (e.g. gonorrhoea and
SUMMARY OF THEEVIDENCE
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chlamydia may rest rict t he use of some medicines, There is low qualit y evidence from eight non-
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LQFLGHQFH RI FKODP\GLD WKH FRVW GLHUHQFHV EHWZHHQ D]LWKURP\FLQ VHH :HE DQQH[HV ' DQG ( 7KHUH DUH
azit hromycin and doxycycline may be large due to no dat a for amoxicillin, eryt hromycin and quinolones.
greater numbers of people requiring t reat ment . (YLGHQFH VKRZHG WKDW WKHUH PD\ EH IHZHU
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In summary, t here was moderate qualit y evidence
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WR (YLGHQFH IURP VWXGLHV RI JHQLWDO LQIHFWLRQV
azit hromycin and doxycycline, and alt hough t he cost
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of azit hromycin is higher, t he single dose may make
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it more convenient to use t han doxycycline. While t he
t here are fewer women t han men in t he studies, t he
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t he evidence is low qualit y and t hese are t herefore
men and women. There is no evidence relat ing to pat ient
provided as alternat ives, wit h t he except ion of delayed-
values and preferences, but t he GDG agreed t hat
release doxycycline, which is current ly expensive.
t here are no known reasons to suspect values would
See Annex C for list of references of reviewed evidence, YDU\ IRU GLHUHQW SHRSOH 7KHUH LV OLWWOH WR QR HYLGHQFH
and Web annex D for det ails of t he evidence reviewed, for accept abilit y, but research in ot her condit ions
LQFOXGLQJ HYLGHQFH SUROHV DQG HYLGHQFH WR GHFLVLRQ indicates t hat adherence may be improved wit h simpler
IUDPHZRUNV SS medicat ion regimens. There is also lit t le to no evidence
for equit y issues and feasibilit y, but azit hromycin is
more expensive and t ypically t he cost is t ransferred
4.2 ANORECTAL CHLAMYDIAL INFECTION
to consumers. The GDG agreed t hat equit y may vary
bet ween t he medicines depending on t he populat ion:
RECOMMENDATION 2
in some populat ions, azit hromycin may be more
In people wit h anorect al chlamydial infect ion, t he accept able since it is a single- dose t reat ment ,
:+2 67, JXLGHOLQH VXJJHVWV XVLQJ GR[\F\FOLQH PJ and some people may experience st igma related to
orally t wice daily for 7 days over azit hromycin 1 g orally visibilit y of a mult i- dose regimen wit h doxycycline.
single dose. Therefore, suggest ing doxycycline over azit hromycin
could create inequit y for people sensit ive to st igma
related to mult i- dose regimens. Azit hromycin is
current ly not list ed as an essent ial medicine for
anorect al chlamydial infect ion.
WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 19
Condit ional recommendation, low qualit y evidence Much of t he evidence was uncert ain for fet al
outcomes as it came from indirect comparisons in
RECOMMENDATION 3C large cohort studies. There were few event s, and
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In pregnant women wit h genit al chlamydial infect ion, included t he potent ial for fewer or more event s
t he WHO STI guideline suggest s using amoxicillin bet ween comparisons.
over eryt hromycin.
In summary, t he GDG agreed t hat azit hromycin is
Condit ional recommendation, low qualit y evidence preferred over eryt hromycin because of greater
Dosages: HHFWLYHQHVV DQG ORZHU FRVW DQG SUHIHUUHG RYHU
DPR[LFLOOLQ GXH WR JUHDWHU HHFWLYHQHVV $]LWKURP\FLQ
azit hromycin 1 g orally as a single dose PD\ DOVR EH PRUH DFFHSWDEOH GXH WR VLQJOH GRVDJH
DPR[LFLOOLQ PJ RUDOO\ WKUHH WLPHV D GD\ IRU GD\V however, it may not be available in all set t ings due to
HU\WKURP\FLQ PJ RUDOO\ IRXU WLPHV D GD\ IRU misconcept ions t hat it is cost ly. Amoxicillin is preferred
days. over eryt hromycin as it is less cost ly and may result in
JUHDWHU EHQHWV DQG IHZHU VLGH HHFWV
Remarks: $]LWKURP\FLQ LV WKH UVW FKRLFH RI
t reat ment but may not be available in some set t ings. See Annex C for list of references of reviewed evidence,
Azit hromycin is less expensive t han eryt hromycin and Web annex D for det ails of t he evidence reviewed,
and since it is provided as a single dose, may result in LQFOXGLQJ HYLGHQFH SUROHV DQG HYLGHQFH WR GHFLVLRQ
bet ter adherence and t herefore bet ter outcomes. IUDPHZRUNV SS
4.4 LYMPHOGRANULOMA VENEREUM (LGV) agreed t hat t hese may be dependent on individuals and
count ries. Dat a for medicine prices and procurement
RECOMMENDATION 4 indicate t hat doxycycline is cheaper t han azit hromycin
and eryt hromycin, alt hough t he lat ter medicines are
In adult s and adolescent s wit h LGV, t he WHO STI
st ill inexpensive.
JXLGHOLQH VXJJHVWV XVLQJ GR[\F\FOLQH PJ RUDOO\
t wice daily for 21 days over azit hromycin 1 g orally, In summary, t here is very low qualit y evidence for all
weekly for 3 weeks. medicines for t reat ment of LGV. The evidence suggest s
ODUJH EHQHWV ZLWK GR[\F\FOLQH RYHU D]LWKURP\FLQ DQG
Condit ional recommendation, very low qualit y evidence
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Remarks: Good pract ice dict ates t reat ment of LGV, doxycycline is t he least expensive.
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See Annex C for list of references of reviewed evidence,
and for people living wit h HIV. When doxycycline is
and Web annex D for det ails of t he evidence reviewed,
cont raindicated, azit hromycin should be provided.
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When neit her t reat ment is available, eryt hromycin
IUDPHZRUNV SS
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alternat ive. Doxycycline should not be used in
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RECOMMENDATION 5
Research implicat ions: Addit ional research for each
of t he t reat ment s and t he dosages recommended is In neonates wit h chlamydial conjunct ivit is, t he WHO
needed, in part icular for eryt hromycin and azit hromycin. STI guideline recommends using oral azit hromycin
Randomized cont rolled t rials should be conducted, PJ NJ GD\ RUDOO\ RQH GRVH GDLO\ IRU GD\V RYHU
measuring crit ical and import ant outcomes, such HU\WKURP\FLQ PJ NJ GD\ RUDOO\ LQ IRXU GLYLGHG
as clinical cure, microbiological cure, complicat ions, doses daily for 14 days.
VLGH HHFWV LQFOXGLQJ DOOHUJ\ WR[LFLW\ JDVWURLQWHVWLQDO
St rong recommendation, very low qualit y evidence
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compliance and LGV t ransmission to part ners. Remarks: This is a st rong recommendat ion given
7KH HHFWV RI VKRUWHU FRXUVHV RI WUHDWPHQW VKRXOG t he potent ial for t he risk of pyloric stenosis wit h t he
also be invest igated. use of eryt hromycin in neonates. In some set t ings,
azit hromycin suspension is not available and t herefore
SUMMARY OF THEEVIDENCE HU\WKURP\FLQ PD\ EH XVHG 6LGH HHFWV VKRXOG EH
monitored wit h t he use of eit her medicat ion.
There is very low qualit y evidence from 12 non-
randomized studies wit h no comparisons bet ween Research implicat ions: Addit ional research should be
t reat ment s. These studies assessed t reat ment FRQGXFWHG WR GHWHUPLQH WKH HHFWV RI WKHVH PHGLFLQHV
wit h azit hromycin and doxycycline for 21 days, and WR WUHDW RSKWKDOPLD QHRQDWRUXP 7KH HHFWV RI RWKHU
eryt hromycin for 14 days. Evidence for doxycycline medicat ions such as t rimet hoprim should also be
VKRZHG WKDW WKHUH PD\ EH ODUJH EHQHWV FOLQLFDO DQG invest igated. Pyloric stenosis should be monitored
PLFURELRORJLFDO FXUH UDWHV JUHDWHU WKDQ DQG or research conducted to evaluat e t his risk wit h
WULYLDO VLGH HHFWV H J SHUVLVWHQW PXFRXV PHPEUDQH t he medicines suggested.
DEQRUPDOLWLHV SHULUHFWDO DEVFHVV DQG DOOHUJ\
7KH HHFWV RI D]LWKURP\FLQ DQG HU\WKURP\FLQ ZHUH SUMMARY OF THEEVIDENCE
uncert ain, wit h only 14 people receiving azit hromycin
There is low qualit y evidence for a cure rate of 98% wit h
and 31 people receiving eryt hromycin in t he studies.
HU\WKURP\FLQ PJ NJ GD\ IRU GD\V DQG XQFHUWDLQ
6LGH HHFWV DUH OLNHO\ WULYLDO DQG VLPLODU WR WKH VLGH
HHFWV RQ WKH FXUH UDWH IRU D]LWKURP\FLQ JLYHQ WKH
HHFWV RI WKHVH WUHDWPHQWV LQ SHRSOH ZLWK RWKHU
small numbers of neonates receiving azit hromycin in
chlamydial infect ions. There is no evidence relat ing
WKH VWXG\ VHH :HE DQQH[HV ' DQG ( 7KHUH LV YHU\ ORZ
to pat ient values and preferences, but t he GDG
qualit y evidence for 7 more inst ances of pyloric stenosis
agreed t hat t here are no known reasons to suspect
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YDOXHV ZRXOG YDU\ IRU GLHUHQW SHRSOH 7KHUH LV OLWWOH
ULVN RI S\ORULF VWHQRVLV DV D VHULRXV DGYHUVH HHFW
to no evidence for accept abilit y, but research in ot her
of eryt hromycin use in children. There are no dat a
condit ions indicates t hat adherence may be improved
evaluat ing pyloric stenosis due to use of azit hromycin.
wit h simpler medicat ion regimens. There is lit t le
7KHUH DUH DOVR QR GDWD DVVHVVLQJ WKH HHFWV RI
evidence for equit y issues and feasibilit y, but t he GDG
WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 21
t rimet hoprim. There is no evidence for variat ion in SUMMARY OF THE EVIDENCE
pat ient values and preferences, but compliance wit h
Overall, t he qualit y of evidence is low to very low
t reat ment s ranged from 77% to 89%. The cost s for t
IURP VWXGLHV UDQGRPL]HG VWXGLHV DQG RQH
reat ment s are relat ively low and similar, and most
non- randomized study wit h t wo comparison
t reat ment s are current ly being used.
JURXSV 7KHUH DUH IHZ DYDLODEOH GDWD IRU WKH HHFWV
In summary, azit hromycin is preferred over RI FKORUDPSKHQLFRO /DUJH EHQHWV ZHUH UHSRUWHG
eryt hromycin because of t he potent ial risk of serious for prophylaxis compared wit h no prophylaxis, in
adverse event s wit h eryt hromycin, and t here are no part icular in babies born to women wit h known infect ion
dat a for t rimet hoprim. DSSUR[LPDWHO\ UHGXFWLRQ LQ FRQMXQFWLYLWLV ZLWK
SURSK\OD[LV XVLQJ GLHUHQW PHGLFDWLRQV 7KH EHQHWV
See Annex C for list of references of reviewed evidence,
ZLWK GLHUHQW PHGLFDWLRQV DUH VLPLODU KRZHYHU WKH ORZ
and Web annex D for det ails of t he evidence reviewed,
WR YHU\ ORZ TXDOLW\ HYLGHQFH LQGLFDWHV WKDW WKH EHQHWV
LQFOXGLQJ HYLGHQFH SUROHV DQG HYLGHQFH WR GHFLVLRQ
of tet racycline hydrochloride, eryt hromycin or povidone
IUDPHZRUNV SS
iodine may be slight ly greater t han for silver nit rate.
REFERENCES
1. Newman L, Rowley J, Vander Hoorn S, Wijesooriya NS, Unemo M, Low N et al. Global est imat es of t he
SUHYDOHQFH DQG LQFLGHQFH RI IRXU FXUDEOH VH[XDOO\ WUDQVPLWWHG LQIHFWLRQV LQ EDVHG RQ V\VWHPDWLF
UHYLHZ DQG JOREDO UHSRUWLQJ 3/R6 2QH H GRL MRXUQDO SRQH
2. Harryman L, Blee K, Horner P. Chlamydiatrachomatis and non- gonococcal uret hrit is. Medicine.
GRL M PSPHG
3. Haggert y CL, Got t lieb SL, Taylor BD, Low N, Xu F, Ness RB. Risk of sequelae aft er Chlamydia
t rachomatis JHQLWDO LQIHFWLRQ LQ ZRPHQ - ,QIHFW 'LV 6XSSO 6 GRL
7. Guidelines for t he management of sexually t ransmit t ed infect ions. Geneva: World Healt h
2UJDQL]DWLRQ KWWS ZZZ ZKR LQW KLY SXE VWL HQ 67,*XLGHOLQHV SGI DFFHVVHG
0D\
8. Manhart LE, Gillespie CW, Lowens MS, Khosropour CM, Colombara DV, Golden MRet al. St andard
t reat ment regimens for nongonococcal uret hrit is have similar but declining cure rat es: a randomized
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:+2 KDQGERRN IRU JXLGHOLQH GHYHORSPHQW QG HGLWLRQ *HQHYD :RUOG +HDOWK 2UJDQL]DWLRQ
KWWS ZZZ ZKR LQW NPV KDQGERRNB QGBHG SGI DFFHVVHG 0D\
0DQDJHPHQW 6FLHQFHV IRU +HDOWK 06+ DQG :RUOG +HDOWK 2UJDQL]DWLRQ :+2 ,QWHUQDWLRQDO GUXJ
SULFH LQGLFDWRU JXLGH HGLWLRQ XSGDWHG DQQXDOO\ 0HGIRUG 0$ 06+ KWWS DSSV ZKR LQW
PHGLFLQHGRFV GRFXPHQWV V HQ V HQ SGI DFFHVVHG 0D\
:+2 JXLGHOLQHV IRU GHFODUDWLRQ RI LQWHUHVWV :+2 H[SHUWV *HQHYD :RUOG +HDOWK 2UJDQL]DWLRQ
,QWURGXFLQJ :+2V UHSURGXFWLYH KHDOWK JXLGHOLQHV DQG WRROV LQWR QDWLRQDO SURJUDPPHV SULQFLSOHV
DQG SURFHVVHV RI DGDSWDWLRQ DQG LPSOHPHQWDWLRQ *HQHYD :RUOG +HDOWK 2UJDQL]DWLRQ KWWS
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ZKR LQW VHOHFWLRQBPHGLFLQHV FRPPLWWHHV H[SHUW (0/B B),1$/BDPHQGHGB$8* SGI
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WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 23
ANNEX A:
STI GUIDELINE DEVELOPMENT TEAMS
18. Lori Newman Depart ment of Reproduct ive Healt h and Research
Human Reproduct ion Team
19. Annet t e Mwansa Nkowane Depart ment of Healt h Workforce
Anit a Sands Essent ial Medicines and Healt h Product s,
3UHTXDOLFDWLRQ 7HDP
21. Igor Toskin Depart ment of Reproduct ive Healt h and Research
Human Reproduct ion Team
22. Marco Vit oria Depart ment of HIV/ AIDS
Treat ment and Care
WHO STI Secret ariat Depart ment and Team
23. Ian Askew Depart ment of Reproduct ive Healt h and Research
Human Reproduct ion Team
24. 1DWKDOLH %URXWHW FR OHDG RI WKH Depart ment of Reproduct ive Healt h and Research
development process) Human Reproduct ion Team
25. James Kiarie Depart ment of Reproduct ive Healt h and Research
Human Reproduct ion Team
Lee Sharkey Depart ment of Reproduct ive Healt h and Research
Human Reproduct ion Team
27. Teodora Elvira Wi (lead of t he Depart ment of Reproduct ive Healt h and Research
development process) Human Reproduct ion Team
METHODOLOGIST
Nancy Sant esso
Depart ment of Clinical Epidemiology and Biost at ist ics
McMaster Universit y
0DLQ 6WUHHW :HVW
Hamilton, Ont ario L8N 3Z5
Canada
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WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 29
1. Andrew Amato
2. Harrell Chesson
3. Craig Cohen
4. Pat ricia Garcia
5. Nicola Low
David Mabey
7. Angelica Miranda
8. Francis Ndowa
9. .HLWK 5DGFOLH
Judit h Stephenson
11. Magnus Unemo
12. Bea Vuylsteke
13. Judit h Wasserheit
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32 WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS
ANNEX B:
DETAILED METHODS FOR GUIDELINE DEVELOPMENT
QUESTIONS AND OUTCOMES E 67, FRQGLWLRQV QRW LQFOXGHG LQ WKH :+2 67,
guidelines t hat were selected by t he GDG to be
To determine which recommendat ions to update,
reviewed and added in t he new WHO STI guidelines.
LQ 'HFHPEHU WKH :RUOG +HDOWK 2UJDQL]DWLRQ
These are import ant and common condit ions.
:+2 'HSDUWPHQW RI 5HSURGXFWLYH +HDOWK DQG
Research reviewed current recommendat ions of key F 67, FRQGLWLRQV LQFOXGHG LQ WKH :+2 67,
internat ional guidelines: guidelines t hat were not updated but were selected
by t he GDG to be included in t he new WHO STI
Sexually t ransmit ted diseases t reat ment guidelines,
guidelines. These STI condit ions are rare and
'HSDUWPHQW RI +HDOWK DQG +XPDQ 6HUYLFHV
diagnosis is not often made in t he majorit y of
United St ates Centers for Disease Cont rol and
set t ings, or it is unlikely t hat t here is new informat ion
3UHYHQWLRQ &'& 4
available as a basis for making any changes to t he
United Kingdom nat ional guidelines for t he :+2 67, UHFRPPHQGDWLRQV
management of sexually t ransmit ted infect ions,
Brit ish Associat ion for Sexual Healt h and HIV G 67, FRQGLWLRQV QRW LQFOXGHG LQ WKH :+2 67,
%$6++ 5 guidelines t hat are part of ot her nat ional guidelines,
but were not selected by t he GDG to be included
Canadian guidelines on sexually t ransmit ted
in t he new WHO STI guidelines. These condit ions
infect ions, Public Healt h Agency of Canada,
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of set t ings, or it is unlikely t hat new research or
European sexually t ransmit ted infect ions guidelines, LQIRUPDWLRQ KDV EHFRPH DYDLODEOH WKHUH DUH H[LVWLQJ
Internat ional Union of Sexually Transmit ted recommendat ions for t hese condit ions t hat can be
,QIHFWLRQV ,867, 7 applied in ot her set t ings (e.g. reference hospit als
Nat ional management guidelines for sexually WKDW PDQDJH FRPSOLFDWHG FRQGLWLRQV
t ransmissible infect ions, Sexual Healt h Societ y
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Nat ional guideline for t he management and cont rol decided on t he init ial list of populat ion, intervent ion,
RI VH[XDOO\ WUDQVPLWWHG LQIHFWLRQV 67,V 1DWLRQDO FRPSDUDWRU DQG RXWFRPH 3,&2 TXHVWLRQV LGHQWLHG
'HSDUWPHQW RI +HDOWK 6RXWK $IULFD 9 and by WHO. After t he meet ing, surveys pert aining to each
Nat ional guidelines on prevent ion, management of t he four STI topic areas (i.e. gonorrhoea, chlamydia,
and cont rol of reproduct ive t ract infect ions including V\SKLOLV DQG KHUSHV VLPSOH[ YLUXV W\SH >+69 @ ZHUH
sexually t ransmit ted infect ions, Minist ry of Healt h administered among subgroups of t he GDG members
and Family Welfare, Government of India, wit h expert ise relat ing to t he relevant STIs. The goal
$XJXVW of t he surveys was to rank t he populat ion, intervent ions
DQG RXWFRPHV IRU HDFK VSHFLF 67, FRQGLWLRQ E\
Based on t he review, four proposed categories
import ance. The surveys required t he members of
RI VH[XDOO\ WUDQVPLWWHG LQIHFWLRQ 67, FRQGLWLRQV
t he STI subgroups to rank t he populat ion, intervent ions
were priorit ized:
and outcomes on a scale of 1 to 9, from lowest to
D 67, FRQGLWLRQV LQFOXGHG LQ WKH :+2 67, highest priorit y.
guidelines11 t hat were selected by t he GDG to be
reviewed and updated in t he new WHO STI guidelines.
These are import ant and common condit ions.
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7 Available at : ht t p:// www.iust i.org/ regions/ europe/ euroguidelines.ht m
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WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 33
)RXU GLHUHQW SULRULW\ 67, VXUYH\V ZHUH FRQGXFWHG The number of comparisons in each quest ion was also
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from t he STI subgroup members. The survey result s for wit h each ot her and wit h import ant intervent ions.
priorit y populat ions, intervent ions and outcomes were Thus, import ant intervent ions were not compared
analysed. Populat ions, intervent ions and outcomes wit h to each ot her.
DQ DYHUDJH UDWLQJ RI WR ZHUH FRQVLGHUHG FULWLFDO
A revised list of quest ions was t hen compiled and all
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members of t he full STI GDG were requested to review
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t he priorit y quest ions. The priorit y quest ions were
3 were considered not import ant and were t hus not
t hen revised based on t his feedback.
covered in t he guidelines. Some quest ions t hat scored
less t han 7 were kept for consistency. 6L[ TXHVWLRQV ZHUH LGHQWLHG IRU WKH XSGDWH RI WKH
chlamydial infect ions guideline. Each quest ion is
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to a recommendat ion.
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on use of resources and obt ained dat a on direct cost s
of medicines.
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t he GDG, an est imate of t he cost associat ed wit h each
alternat ive was calculated. This cost ing est imate refers
only to t he actual market price of t he medicat ion and
does not include t he cost s of ot her resources t hat
could be involved, such as syringes, inject ion t ime or
needle disposal.
Dat a were presented in a t able and included: t reat ment ,
dose per day, t reat ment durat ion, days, medicine cost
per dose, medicine cost per full course of t reat ment ,
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price for a full course of t reat ment for each medicine by
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mult iplied by t he number of days of t he t reat ment , plus
25% of t he procurement cost s for t he medicines used.
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drug price indicator guide and informat ion available
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based on assumpt ions about t he cost per unit of
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(MEDLINE, Embase and t he Cochrane Library for
Economic Evaluat ion and Technology Assessment
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and abst racted dat a regarding possible resources to be
considered during t he decision- making process.
ANNEX C:
LISTS OF REFERENCES FOR REVIEWED EVIDENCE
RECOMMENDATION 1 11. Ibsen HH, Mller BR, Halkier- Srensen L, From E. Treat ment
RI QRQJRQRFRFFDO XUHWKULWLV FRPSDULVRQ RI RR[DFLQ DQG
HU\WKURP\FLQ 6H[ 7UDQVP 'LV
Treat ment s for adult s and adolescent s wit h
uncomplicat ed genit al (cervix, uret hra) 12. Kitchen VS, Donegan C, Ward H, Thomas B, Harris JR, Taylor-
5RELQVRQ ' &RPSDULVRQ RI RR[DFLQ ZLWK GR[\F\FOLQH LQ WKH
chlamydial infect ions t reat ment of non- gonococcal uret hrit is and cervical chlamydial
LQIHFWLRQ - $QWLPLFURE &KHPRWKHU 6XSSO '
Syst emat ic review
13. Lauharant a J, Saarinen K, Must onen MT, Happonen HP.
1. Pez- Canro C, Mart inez- Mart inez F, Alzat e JP, Let haby A, Gait n Single- dose oral azit hromycin versus seven- day doxycycline
HG. Ant ibiot ics for t reat ing genit al Chlamydiatrachomatis in t he t reat ment of non- gonococcal uret hrit is in males. J
LQIHFWLRQ LQ PHQ DQG QRQ SUHJQDQW ZRPHQ SURWRFRO $QWLPLFURE &KHPRWKHU 6XSSO (
&RFKUDQH 'DWDEDVH 6\VW 5HY &'
14. List er PJ, Balechandran T, Ridgway GL, Robinson AJ.
Comparison of azit hromycin and doxycycline in t he t reat ment
Included st udies
of non- gonococcal uret hrit is in men. J Ant imicrob Chemot her.
1. Bowie WR, Yu JS, Fawcet t A, Jones HD. Tet racycline in 6XSSO (
nongonococcal uret hrit is. Comparison of 2 g and 1 g daily
15. Manhart LE, Gillespie CW, Lowens MS, Khosropour CM,
IRU VHYHQ GD\V %U - 9HQHU 'LV
Colombara DV, Golden MR, et al. St andard t reat ment regimens
2. Campbell WF, Dodson MG. Clindamycin t herapy for Chlamydia for nongonococcal uret hrit is have similar but declining
t rachomatis LQ ZRPHQ $P - 2EVWHW *\QHFRO cure rat es: a randomized cont rolled t rial. Clin Infect Dis.
24. Topic A, Skerk V, Punt aric A, Milavec Puret ic V, Beus A, Begovac RECOMMENDATION 2
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pat ient s wit h asympt omat ic urogenit al chlamydial infect ions. J
&KHPRWKHU Treat ment s in adult s and adolescent s wit h
uncomplicat ed anorect al chlamydial infect ions
25. van der Willigen AH, Polak- Vogelzang AA, Habbema L,
:DJHQYRRUW -+ &OLQLFDO HFDF\ RI FLSURR[DFLQ YHUVXV
(excluding lymphogranuloma venereum
doxycycline in t he t reat ment of non- gonococcal uret hrit is
LQ PDOHV (XU - &OLQ 0LFURELRO ,QIHFW 'LV Syst emat ic review
1. Kong FY, Tabrizi SN, Fairley CK, Vodst rcil LA, Hust on WM, Chen
3DWLHQW YDOXHV DQG SUHIHUHQFHV DFFHSWDELOLW\ DQG FRVW VSHFLF WR 0 HW DO 7KH HFDF\ RI D]LWKURP\FLQ DQG GR[\F\FOLQH IRU WKH
chlamydial infect ions t reat ment of rect al chlamydia infect ion: a syst emat ic review
DQG PHWD DQDO\VLV - $QWLPLFURE &KHPRWKHU
1. Dixon- Woods M, Stokes T, Young B, Phelps K, Windridge
GRL MDF GNX
K, Shukla R. Choosing and using services for sexual healt h:
a qualit at ive st udy of women's views. Sex Transm Infect .
Included st udies
,QWHUQDWLRQDO GUXJ SULFH LQGLFDWRU JXLGH HGLWLRQ XSGDWHG 1. Ding A, Challenor R. Rect al chlamydia in het erosexual women:
DQQXDOO\ 0HGIRUG 0$ 0DQDJHPHQW 6FLHQFHV IRU +HDOWK PRUH TXHVWLRQV WKDQ DQVZHUV ,QW - 67' $,'6
KWWS HUF PVK RUJ GPSJXLGH SGI 'UXJ3ULFH*XLGHB SGI GRL
DFFHVVHG -XQH
2. Drummond F, Ryder N, Wand H, Guy R, Read P, McNult y AM, et
3. Sahin- Hodoglugil NN, Woods R, Pet t ifor A, Walsh J. A al. Is azit hromycin adequat e t reat ment for asympt omat ic rect al
FRPSDULVRQ RI FRVW HHFWLYHQHVV RI WKUHH SURWRFROV IRU FKODP\GLD" ,QW - 67' $,'6 GRL
diagnosis and t reat ment of gonococcal and chlamydial infect ions LMVD
LQ ZRPHQ LQ $IULFD 6H[ 7UDQVP 'LV
3. Elgalib A, Alexander S, Tong CY, Whit e JA. Seven days of
GR[\F\FOLQH LV DQ HHFWLYH WUHDWPHQW IRU DV\PSWRPDWLF UHFWDO
Pat ient values and preferences, accept abilit y and cost : ot her Chlamydiatrachomatis LQIHFWLRQ ,QW - 67' $,'6
sexually t ransmit t ed infect ions and condit ions GRL LMVD
1. Kingst on M, Carlin E. Treat ment of sexually t ransmit t ed 4. Hat horn E, Opie C, Goold P. What is t he appropriat e t reat ment
infect ions wit h single- dose t herapy: a double- edged sword. for t he management of rect al Chlamydiatrachomatis in men
'UXJV DQG ZRPHQ" 6H[ 7UDQV ,QIHFW GRL
VH[WUDQV
2. Nagarkar A, Mhaskar P. A syst emat ic review on t he prevalence
and ut ilizat ion of healt h care services for reproduct ive t ract 5. Khosropour CM, Dombrowski JC, Barbee LA, Manhart LE,
infect ions/ sexually t ransmit t ed infect ions: evidence from India. Golden MR. Comparing azit hromycin and doxycycline for
,QGLDQ - 6H[ 7UDQVP 'LV GRL t he t reat ment of rect al chlamydial infect ion: a ret rospect ive
FRKRUW VWXG\ 6H[ 7UDQVP 'LV GRL
2/4
3. Ryan R, Sant esso N, Lowe D, Hill S, Grimshaw J, Prict or M,
HW DO ,QWHUYHQWLRQV WR LPSURYH VDIH DQG HHFWLYH PHGLFLQHV .KRVURSRXU &0 'XDQ 5 0HWVFK /5 )HDVWHU '- *ROGHQ
use by consumers: an overview of syst emat ic reviews. MR. Persist ent / recurrent chlamydial infect ion among STD
&RFKUDQH 'DWDEDVH 6\VW 5HY &' clinic pat ient s t reat ed wit h CDC- recommended t herapies.
Abst ract s of t he STI and AIDS World Congress, Vienna,
Addit ional references $XVWULD 6H[ 7UDQVP ,QIHFW 6XSSO $ GRL
VH[WUDQV
1. Amin A, Garcia Moreno C. Addressing gender- based violence
WR UHGXFH ULVN RI 67, DQG +,9 6H[ 7UDQVP ,QIHFW 7. St eedman NM, McMillan A. Treat ment of asympt omat ic rect al
6XSSO $ GRL VH[WUDQV Chlamydiatrachomatis LV VLQJOH GRVH D]LWKURP\FLQ HHFWLYH" ,QW
- 67' $,'6 GRL LMVD
*OREDO %XUGHQ RI 'LVHDVH 6WXG\ &ROODERUDWRUV *OREDO
regional, and nat ional incidence, prevalence, and years lived 8. Whit e JA. Manifest at ions and management of lymphogranuloma
ZLWK GLVDELOLW\ IRU DFXWH DQG FKURQLF GLVHDVHV DQG LQMXULHV YHQHUHXP &XUU 2SLQ ,QIHFW 'LV GRL
LQ FRXQWULHV D V\VWHPDWLF DQDO\VLV IRU WKH *OREDO 4&2 E H D DH
%XUGHQ RI 'LVHDVH 6WXG\ /DQFHW
GRL 6 3DWLHQW YDOXHV DQG SUHIHUHQFHV DFFHSWDELOLW\ DQG FRVW VSHFLF WR
chlamydial infect ions
3. Holmes K. Sexually t ransmit t ed diseases, 4t h edit ion. New York
1< 0F*UDZ +LOO 1. Dixon- Woods M, Stokes T, Young B, Phelps K, Windridge
K, Shukla R. Choosing and using services for sexual healt h:
4. Newman L, Rowley J, Vander Hoorn S, Wijesooriya NS, Unemo
a qualit at ive st udy of women's views. Sex Transm Infect .
M, Low N, et al. Global est imat es of t he prevalence and LQFLGHQFH
RI IRXU FXUDEOH VH[XDOO\ WUDQVPLWWHG LQIHFWLRQV LQ based on
syst emat ic review and global report ing. PLoS One. ,QWHUQDWLRQDO GUXJ SULFH LQGLFDWRU JXLGH HGLWLRQ XSGDWHG
H GRL MRXUQDO SRQH DQQXDOO\ 0HGIRUG 0$ 0DQDJHPHQW 6FLHQFHV IRU +HDOWK
KWWS HUF PVK RUJ GPSJXLGH SGI 'UXJ3ULFH*XLGHB SGI
DFFHVVHG -XQH
WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS 41
Pat ient values and preferences, accept abilit y and cost : ot her 5. Bush MR, Rosa C. Azit hromycin and eryt hromycin in t he
sexually t ransmit t ed infect ions and condit ions t reat ment of cervical chlamydial infect ion during pregnancy.
2EVWHW *\QHFRO
1. Nagarkar A, Mhaskar P. A syst emat ic review on t he prevalence
and ut ilizat ion of healt h care services for reproduct ive t ract &URPEOHKROPH :5 6FKDFKWHU - *URVVPDQ 0 /DQGHUV '9
infect ions/ sexually t ransmit t ed infect ions: evidence from India. Sweet RL. Amoxicillin t herapy for Chlamydiatrachomatis in
,QGLDQ - 6H[ 7UDQVP 'LV GRL SUHJQDQF\ 2EVWHW *\QHFRO
7. Edwards MS, Newman RB, Cart er SG, Leboeuf FW, Menard MK,
2. Ryan R, Sant esso N, Lowe D, Hill S, Grimshaw J, Prict or M, Rainwat er KP. Randomized clinical t rial of azit hromycin for t he t
HW DO ,QWHUYHQWLRQV WR LPSURYH VDIH DQG HHFWLYH PHGLFLQHV reat ment of Chlamydia cervicit is in pregnancy. Infect Dis
use by consumers: an overview of syst emat ic reviews. 2EVWHW *\QHFRO
&RFKUDQH 'DWDEDVH 6\VW 5HY &'
8. Jacobson GF, Aut ry AM, Kirby RS, Liverman EM, Mot ley RU.
A randomized cont rolled t rial comparing amoxicillin and
Addit ional references azit hromycin for t he t reat ment of Chlamydiatrachomatis in
1. Amin A, Garcia Moreno C. Addressing gender- based SUHJQDQF\ $P - 2EVWHW *\QHFRO
violence t o reduce risk of STI and HIV. Sex Transm Infect . 9. Kacmar J, Cheh E, Mont agno A, Peipert JF. A randomized
6XSSO $ t rial of azit hromycin versus amoxicillin for t he t reat ment of
*OREDO %XUGHQ RI 'LVHDVH 6WXG\ &ROODERUDWRUV *OREDO Chlamydiatrachomatis in pregnancy. Infect Dis Obst et Gynecol.
regional, and nat ional incidence, prevalence, and years lived
ZLWK GLVDELOLW\ IRU DFXWH DQG FKURQLF GLVHDVHV DQG LQMXULHV LQ 0DJDW $+ $OJHU /6 1DJH\ '$ +DWFK 9 /RYFKLN -& 'RXEOH
FRXQWULHV D V\VWHPDWLF DQDO\VLV IRU WKH *OREDO blind randomized st udy comparing amoxicillin and eryt hromycin
%XUGHQ RI 'LVHDVH 6WXG\ /DQFHW for t he t reat ment of Chlamydiatrachomatis in pregnancy. Obst et
GRL 6 *\QHFRO 3W
3. Holmes K. Sexually t ransmit t ed diseases, 4t h edit ion. New York 11. Mart in DH, Eschenbach DA, Cot ch MF, Nugent RP, Rao AV,
1< 0F*UDZ +LOO .OHEDQR 0$ HW DO 'RXEOH EOLQG SODFHER FRQWUROOHG WUHDWPHQW
4. Newman L, Rowley J, Vander Hoorn S, Wijesooriya NS, Unemo t rial of Chlamydiatrachomatis endocervical infect ions in
M, Low N, et al. Global est imat es of t he prevalence and SUHJQDQW ZRPHQ ,QIHFW 'LV 2EVWHW *\QHFRO
LQFLGHQFH RI IRXU FXUDEOH VH[XDOO\ WUDQVPLWWHG LQIHFWLRQV LQ 1DGD 0 $EGDOL .+ 3DUVDQHMDG 0( 5DMDHH )DUG $5 .DYLDQL 0
based on syst emat ic review and global report ing. PLoS One. A comparison of amoxicillin and eryt hromycin for asympt omat ic
H GRL MRXUQDO SRQH Chlamydiatrachomatis infect ion in pregnancy. Int J Gynaecol
2EVWHW
RECOMMENDATIONS 3A, 3B, 3C 13. Rahangdale L, Guerry S, Bauer HM, Packel L, Rhew M, Baxt er R,
et al. An observat ional cohort st udy of Chlamydiatrachomatis
WUHDWPHQW LQ SUHJQDQF\ 6H[ 7UDQVP 'LV
Treat ment s in pregnant women wit h chlamydial
infect ions 14. Rosenn M, Macones GA, Silverman N. A randomized t rial of
eryt hromycin and azit hromycin for t he t reat ment of chlamydia
LQIHFWLRQ LQ SUHJQDQF\ $P - 2EVWHW *\QHFRO
Syst emat ic review
15. Rosenn MF, Macones GA, Silverman NS. Randomized t rial
1. Brocklehurst P, Gordon A, Heat ley E, Milan SJ. Ant ibiot ics for t
of eryt hromycin and azit hromycin for t reat ment of
reat ing bact erial vaginosis in pregnancy. Cochrane Dat abase
chlamydial infect ion in pregnancy. Infect Dis Obst et Gynecol.
6\VW 5HY &'
3DWLHQW YDOXHV DQG SUHIHUHQFHV DFFHSWDELOLW\ DQG FRVW VSHFLF WR 8. Sandst rm I. Treat ment of neonat al conjunct ivit is. Arch
chlamydial infect ions 2SKWKDOPRO
,QWHUQDWLRQDO GUXJ SULFH LQGLFDWRU JXLGH HGLWLRQ XSGDWHG 9. Sandst rm I, Kallings I, Melen B. Neonat al chlamydial
DQQXDOO\ 0HGIRUG 0$ 0DQDJHPHQW 6FLHQFHV IRU +HDOWK conjunct ivit is. A long t erm follow- up st udy. Act a Paediat ri Scand.
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DFFHVVHG -XQH
6WHQEHUJ . 0UGK 3$ &KODP\GLDO FRQMXQFWLYLWLV LQ QHRQDWHV DQG
2. Sahin- Hodoglugil NN, Woods R, Pet t ifor A, Walsh J. A DGXOWV +LVWRU\ FOLQLFDO QGLQJV DQG IROORZ XS $FWD 2SKWKDOPRO
FRPSDULVRQ RI FRVW HHFWLYHQHVV RI WKUHH SURWRFROV IRU
diagnosis and t reat ment of gonococcal and chlamydial infect ions
LQ ZRPHQ LQ $IULFD 6H[ 7UDQVP 'LV 6WHQEHUJ . 0UGK 3 $ 7UHDWPHQW RI FKODP\GLDO FRQMXQFWLYLWLV
in newborns and adult s wit h eryt hromycin and roxit hromycin.
- $QWLPLFURE &KHPRWKHU
Pat ient values and preferences, accept abilit y and cost
1. Nagarkar A, Mhaskar P. A syst emat ic review on t he prevalence 3DWLHQW YDOXHV DQG SUHIHUHQFHV DFFHSWDELOLW\ DQG FRVW VSHFLF WR
and ut ilizat ion of healt h care services for reproduct ive t ract chlamydial infect ions
infect ions/ sexually t ransmit t ed infect ions: evidence from India.
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$ FRVW HHFWLYHQHVV DQDO\VLV RI WKH &KODP\GLD 0RQGD\ D
communit y- based int ervent ion t o decrease t he prevalence of
2. Ryan R, Sant esso N, Lowe D, Hill S, Grimshaw J, Prict or M, FKODP\GLD LQ 6ZHGHQ 6FDQG - 3XEOLF +HDOWK
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use by consumers: an overview of syst emat ic reviews.
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&RFKUDQH 'DWDEDVH 6\VW 5HY &' DQQXDOO\ 0HGIRUG 0$ 0DQDJHPHQW 6FLHQFHV IRU +HDOWK
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Addit ional references
Included st udies
RECOMMENDATIONS 6 AND 7
&RRSHU :2 *ULQ 05 $UERJDVW 3 +LFNVRQ *% *DXWDP 6
Ray WA. Very early exposure t o eryt hromycin and infant ile Prevent ion of gonococcal and chlamydial
hypert rophic pyloric st enosis. Arch Pediat r Adolesc Med.
opht halmia neonat orum
2. Fransen L, Nsanze H, D'Cost a L. Oral eryt hromycin est olat e Syst emat ic reviews
in nongonococcal neonat al conjunct ivit is. Eur J Sex Transm
'LV 'DUOLQJ (. 0F'RQDOG + $ PHWD DQDO\VLV RI WKH HFDF\ RI RFXODU
prophylact ic agent s used for t he prevent ion of gonococcal
+HJJLH $' -DH $& 6WXDUW /$ 7KRPEUH 36 6RUHQVHQ 58 and chlamydial opht halmia neonat orum. J Midwifery Womens
Topical sulfacet amide vs oral eryt hromycin for neonat al +HDOWK GRL M MPZK
FKODP\GLDO FRQMXQFWLYLWLV $P - 'LV &KLOG
2. Kapoor VS, Whyt e R, LaRoche RR. Int ervent ions for
4. Hammerschlag MR, Chandler JW, Alexander ER, English M, SUHYHQWLQJ RSKWKDOPLD QHRQDWRUXP LQWHUYHQWLRQ SURWRFRO
Kout sky L. Longit udinal st udies on chlamydial infect ions in &RFKUDQH 'DWDEDVH 6\VW 5HY &'
WKH UVW \HDU RI OLIH 3HGLDWU ,QIHFW 'LV
3. Mabry- Hernandez IR, Koenig HC. Ocular prophylaxis for
5. Hammerschlag,MR, Gelling M., Roblin PM, Kut lin A, Jule gonococcal opht halmia neonat orum: evidence updat e
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D]LWKURP\FLQ 3HGLDWU ,QIHFW 'LV - 5HFRPPHQGDWLRQ 6WDWHPHQW $+54 3XEOLFDWLRQ 1R
3DWDPDVXFRQ 35 5HWWLQJ 3- )DXVW ./ .XVPLHV] +7 5RFNYLOOH 0' $JHQF\ IRU +HDOWKFDUH 5HVHDUFK DQG
Nelson JD. Oral v t opical eryt hromycin t herapies for 4XDOLW\
FKODP\GLDO FRQMXQFWLYLWLV $P - 'LV &KLOG =XSSD $$ '$QGUHD 9 &DWHQD]]L 3 6FRUUDQR $ 5RPDJQROL
C. Opht halmia neonat orum: what kind of prophylaxis?
7. Rosenman MB, Mahon BE, Downs SM, Kleiman MB. Oral
eryt hromycin prophylaxis vs wat chful wait ing in caring
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for newborns exposed t o Chlamydiatrachomatis.
$UFK 3HGLDWU $GROHVF 0HG
44 WHO GUIDELINES FORTHE TREATMENT OF CHLAMYDIA TRACHOMATIS
1. Ali Z, Khadije D, Elahe A, Mohammad M, Fat eme Z, 1. Hedberg K, Rist inen TL, Soler JT, Whit e KE, Hedberg CW,
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of bet adine, eryt hromycin and no prophylaxis. J Trop Pediat r. resist ant st aphylococcal conjunct ivit is in a newborn nursery.
3HGLDWU ,QIHFW 'LV -
5. Brussieux J, Boisivon A, Thron HP, Faidherbe C, Machado 2. Isenberg SJ, Apt L, Wood M. A cont rolled t rial of povidone iodine
N, Michelon B. [Prevent ion of neonat al conjunct ivit is. A as prophylaxis against opht halmia neonat orum. N Engl J Med.
comparat ive clinical and bact eriologic st udy of 2 eyedrops:
VLOYHU QLWUDWH DQG R[\WHWUDF\FOLQH@ $QQ 3HGLDWU
3. Ison CA, Terry P, Bendayna K, Gill MJ, Adams J, Woodford N.
LQ )UHQFK
7HWUDF\FOLQH UHVLVWDQW JRQRFRFFL LQ 8. /DQFHW
&KHQ -< 3URSK\OD[LV RI RSKWKDOPLD QHRQDWRUXP FRPSDULVRQ
of silver nit rat e, t et racycline, eryt hromycin and no prophylaxis. 4. Knapp JS, Zenilman JM, Biddle JW, Perkins GH, DeWit t WE,
3HGLDWU ,QIHFW 'LV - Thomas ML, et al. Frequency and dist ribut ion in t he Unit ed
St at es of st rains of Neisseriagonorrhoeae wit h plasmid-
'DYLG 0 5XPHOW 6 :HLQWUDXE = (FDF\ FRPSDULVRQ EHWZHHQ mediat ed, high- level resist ance t o t et racycline. J Infect Dis.
povidone iodine 2.5% and t et racycline 1% in prevent ion of
RSKWKDOPLD QHRQDWRUXP 2SKWKDOPRORJ\
5. Schwarcz SK, Zenilman JM, Schnell D, Knapp JS, Hook EW
8. Fischer PR, Ret a BB. Prevent ion of neonat al conjunct ivit is in 3rd, Thompson S, et al. Nat ional surveillance of ant imicrobial
=DLUH $QQ 7URS 3DHGLDWU resist ance in Neisseriagonorrhoeae. The Gonococcal Isolat e
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9. Hammerschlag MR, Cummings C, Roblin PM, Williams TH,
'HONH , (FDF\ RI QHRQDWDO RFXODU SURSK\OD[LV IRU WKH SUHYHQWLRQ
of chlamydial and gonococcal conjunct ivit is. N Engl J Med. References relat ed t o pat ient values and preferences,
accept abilit y and cost
12. Isenberg SJ, Apt L, Del Signore M, Gichuhi S, Berman NG. ,QWHUQDWLRQDO 'UXJ 3ULFH ,QGLFDWRU *XLGH (GLWLRQ XSGDWHG
A double applicat ion approach t o opht halmia neonat orum DQQXDOO\ 0HGIRUG 0$ 0DQDJHPHQW 6FLHQFHV IRU +HDOWK
SURSK\OD[LV %U - 2SKWKDOPRO KWWS HUF PVK RUJ GPSJXLGH SGI 'UXJ3ULFH*XLGHB SGI
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13. Isenberg SJ, Apt L, Wood M. A cont rolled t rial of povidone- iodine
as prophylaxis against opht halmia neonat orum. N Engl J Med. Addit ional references
19. Zanoni D, Isenberg SJ, Apt L. A comparison of silver nit rat e wit h
eryt hromycin for prophylaxis against opht halmia neonat orum.
&OLQ 3HGLDWU