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Anal Chlamydia Infection clinical trials

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NCT ID: NCT03608774 Completed - Clinical trials for Anal Chlamydia Infection

Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM

Start date: July 13, 2018
Phase: Phase 4
Study type: Interventional

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.