Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM
Status:
Completed
Trial end date:
2020-02-21
Target enrollment:
Participant gender:
Summary
A clinical trial to compare the efficacy of azithromycin (Arm 1) vs. doxycycline (Arm 2)
administered per CDC's STD Treatment Guidelines for rectal Chlamydia trachomatis (CT) in men
who have sex with men (MSM). Subjects will be males aged = / > 18 years with a
microbiologically confirmed diagnosis of rectal CT and at least one male sex partner in the
past 12 months. The trial will be conducted at two sites in the US and will enroll up to 274
total subjects to achieve 246 subjects who contribute to the primary analysis. The duration
of this study will be approximately 16 months 22 months with subject participation duration
29 days. The primary objective of this study is to compare the efficacy of azithromycin vs.
doxycycline for treatment of rectal CT infection in MSM based on microbiologic cure (negative
NAAT) at Day 29.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)