YCFM (Youth Correctional Facilities Males)

The proposed study is a single center (with multiple long-term YCFs) treatment trial of the
CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males residing in
long-term gender-segregated YCFs. This study is designed primarily to determine the frequency
of chlamydia treatment failure following azithromycin in males who do versus do not have
urethral symptoms of urethral discharge and/or dysuria. Males age 12 to 21 years in good
health (based on vital signs and provider's clinical evaluation documented in medical
records) who are residing in long-term gender-segregated (not co-ed) YCFs (usual stay > 3
weeks) and who are identified as chlamydia-infected comprise the study population. The
anticipated enrollment is 446 males with subject participation duration of 28 days and study
duration of 4 years. The primary objective of the study is to assess the microbiological
efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in males with
versus without urethral symptoms in YCFs; in essence, this study will assess the frequency of
chlamydia treatment failure to azithromycin at the Day 28 follow-up visit (Visit 2) in males
with urethral symptoms compared to males without urethral symptoms. The secondary objective
is to evaluate the association of laboratory findings (enrollment chlamydia load and OmpA
genotype) and other participant characteristics (demographics, sexual behaviors, etc.) to
chlamydia treatment failure in males after azithromycin treatment.

Inclusion Criteria:

1.Male between the ages of 12 and 21 years 2.Residing in a long-term gender-segregated (no
co-ed) YCF 3.Diagnosed with urogenital chlamydia as determined by a screening C.
trachomatis NAAT 4.Anticipated length of stay at the YCF at the time of enrollment is at
least 28 days 5.Willingness to provide written consent 6.Willingness to comply with study
procedures

Exclusion Criteria:

1.Diagnosed with gonorrhea as determined by a screening Neisseria gonorrhoeae NAAT
2.Clinical diagnosis of epididymitis based on review of medical records 3.Known allergy to
azithromycin, erythromycin, any macrolide or ketolide drug 4.History of liver problems due
to use of azithromycin 5.Having received antimicrobial therapy with activity against C.
trachomatis within 21 days of the positive chlamydia screening NAAT or in the interval
between the positive screening NAAT and study enrollment 6.Any concomitant infection, which
requires antimicrobial therapy with activity against C. trachomatis 7.Previously enrolled
in this study 8.Unable to swallow pills 9.Other exclusion criteria, per clinician judgment,
that prohibits subject from enrolling in study