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REVIEW JOURNAL

AZITHROMYCIN VERSUS DOXYCYCLINE FOR


UROGENITAL CHLAMYDIA TRACHOMATIS INFECTION
BACKGROUND
Urogenital Chlamydia
The most prevalent
trachomatis
v bacterial sexually
transmitted infection
Effort preventation and control
chlamydia trachomatis  reduction Failed to reduce
In female  PID  sequele prevalence
Ecttopic pregnancy
and infertility CDC recommends 
Result of screening  effective
treatment is effective for control Azithromycin in a single dose or
prevalence chlamdydia 100 mg of doxycyline twice
daily for 7 days
Why doxycyline and From metaanalysis
azithromycin ??

Efficacy azithromycin Efficacy doxycycline


agains chlamydia  agains chlamydia 
97% 98%

Had limitation

Used test were less Reinfection from partner


Theres no repeted test 2-5
senstive and no not be controlled
weeks after treatment
recommended

Adherence to doxycycline Positive test post therapy Difficult to determine relpas from
not ensured difficult determine  incomplete eradication
treatment failure or
Lead to treatmet failure reinfection
Three study of nogonococcal urethritis
other study  showed azithromycin efficacy <90%
in male
In two other study azithromycin
vs rifalazil  azithromycin
efficacy 92%
In this study choose youth correctional facilities,
1. because chlamydia infection high in this population
To addres the limitation of 2. residents of youth correctional facilities are usually not reexposed to
previous studies untreated partners,
3. treatment is directly observed
4. Screening constant all partners from minimalize infection from ne partener

In this study obtained a sexual history

per- formed outer membrane protein A (OmpA) geno- typing on C.


trachomatis strains to more accurately classify treatment outcomes.
METHODS

STUDY DESIGN AND PARTICIPANS

Inclusion criteria :
Male and female 12 – 21 y.o who were residing in four long-term, sex- segregated youth correctional facilities in
Los Angeles.
Positive screening nucleic acid amplification test result and,
after obtaining written informed consen

The study begin from December 2009


Nucleic acid amplification testing to screen for chlamydia (APTIMA Combo 2, Gen-Probe) is routinely performed
Routine gential examination within 96 hours after intake
The exclusion criteria a. receipt of an antibiotic with
a. pregnancy, antichlamydial ac- tivity within
b. breast- feeding, 21 days before screening or be-
c. gonorrhea coinfection, tween screening and enrollment
d. allergy to tetra- cyclines or b. concomitant infection requiring
macrolides, treatment with an antibiotic
e. previous photosensitivity from agent that had antichlamydial
doxycycline, activity,
f. an inability to swallow pills, c. PID or epididymitis
STUDY OVERSIGHT

The study was approved by the institutional review board at the


University of Alabama at Birmingham and at the County of Los
Angeles Public Health Department

Data were collected by LA County study staff, managed by FHI


360 and analyzed by statisticians from the University of Arkansas
for Medical Sciences

Drug  purchased from a pharmacy in Los Angeles with study


funds from the National Institute of Allergy and Infectious Diseases
STUDY PROCEDURE

Confirm Randomly
Interview chlamydia assigned,
Participant infection ratio 1:1

Oral intake  directly observed by youth correctional facility staff

Two database systems were reviewed for previous chlamydia


infections: STD Casewatch Millennium and the Los Angeles County Public Health Laboratory MISYS database system.
FOLLOW UP
Positive result at first FU Classified as having possible
1. anamnesis :symptopms, AB taken treatment failure, and their participant
2. provided a first-catch urine specimen was complete
At day 28
Repeat-test
Negative result at first FU : Attended until second follow up

Negative result at first FU : repeat nucleic acid amplification testing


and anam
At day 67
Repeat-test

Positive result OmpA genotyping performed on their


urine specimens
OUTCOME AND POPULATION USED FOR ANALYSES
concordant
C.Trachomatis
PRIMARY OUTCOME strains (-)

Treatment failure Based on Positive test for C trachomatis and


concordant C.Trachomatis strains basline and make sure :
Follow up participants could not have
had unsupervised furloughs
and could not have had sex
(self-reported)
concordant
were presumed to have new infections and C.Trachomatis
were not considered to have treatment strains (+)
failure
OUTCOME AND POPULATION USED FOR ANALYSES

SECONDARY OUTCOME included treatment efficacy based on the


results of tests from both follow-up visits, as
well as safety.
STATISTICAL ANALYSIS

noninferiority trials was designed to test the null hypothesis that the
absolute rate of azithromycin treatment failure would
be at least 5 percentage points higher than the
absolute rate of doxycycline treatment failure

against the alternative hypothesis that


there would be no difference between
regimens,
STATISTICAL ANALYSIS
SAS software, version 9.3 (SAS Institute). Associations between
ANALYSES
participant characteristics and study group

Associations between participant characteristics and study group or


TREATMENT
treatment failure were evaluated with the use of Fisher’s exact test or a
FAILURE
Wilcoxon rank-sum test

DOCUMENTED PREVIOUS
CHLAMYDIA INFECTION were evaluated with McNemar’s test.
RESULT
STUDY PARTICIPANT

enrolled from December 2009 through April 2014


RESULT
STUDY PARTICIPANT
RESULT

Doxycycline Group NO TREATMENT FAILURE

Azithromycin Group 7 participant test (+) C.Trachomatis in first


Follow up

The difference in failure Re-infection  no Treatment failure


rate between the treatment failure, 5 participants Asymptomatic
treatments was 3.2 2 participant
percentage point
RESULT
TREATMENT ADHEREN AND SAFETY

Azithromycin Two participant vomit within 1 hour after taking it, and a second
dose was administered successfully.
Adverse event  23% (GIT)

Doxycycline 2%  11 dose
3% 12 doses
12%  13 doses
6%  15 dose
1%  16 doses
Adverse event 27%
(GIT) NO PARTICIPANT
DROPOUT
DISCUSSION

DOXYCYCLINE
No treatment we determined adherence the possibility that the efficacy
failure through the staff recording of doxycycline could be offset
directly observed by limited adherence should
treatment be taken into consideration.

AZITHROMYCIN
3% TREATMENT Still unclear
FAILURE
DISCUSSION

the use of youth correctional Minimized :


facilities as the sites for the trial. the possibility of chlamydia re-exposure from
untreated partners, limited exposure from new
partners, and enhanced treatment adherence.

improved accuracy in the detection of treatment failure


with the use of nucleic acid ampli
fication testing and OmpA genotyping
DISCUSSION

performed in a single geographic location


limitattion
urine specimens were used for chlamydia nucleic
acid amplification testing in female participants 
it should be vaginal swab (recommended)

an unexpected challenge in our study was


the high rate of early discharge from youth
correctional facilities
CONCLUSION

IN CONCLUSION, THE NONINFERIORITY OF AZITHROMYCIN TO DOXYCYCLINE WAS NOT


ESTABLISHED IN OUR STUDY. HOWEVER, THE EFFICACY OF BOTH TYPES OF TREATMENT WAS
HIGH (97% AND 100%) IN THE CONTEXT OF A PER-PROTOCOL ANALYSIS AND DIRECTLY
OBSERVED AND MONITORED THERAPY

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