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. 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. Anticipated enrollment is 446 males, between the age of 12 to 21 years old,
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.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)