Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM
Condition: Anal Chlamydia Infection
MeSH terms: Chlamydia Infections
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      A Phase 4, multi-center, randomized, double-blinded, placebo-controlled 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). The
      effect of Lymphogranuloma Venereum (LGV) infection on microbiologic cure in MSM with rectal
      CT will also be assessed. Arm 1 will comprise of subjects receiving 1 gram of Azithromycin (4
      capsules of 250 mg) orally as a single dose, and Doxycycline placebo (1 capsule) orally twice
      daily for 7 days. Arm 2 will comprise of subjects receiving 100 mg of Doxycycline (1 capsule)
      administered orally twice daily for 7 days, and Azithromycin placebo (4 capsules)
      administered orally as a single dose. 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 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. The secondary objectives are: 1) to assess the effect of LGV infection on
      microbiologic cure in MSM with rectal CT at Days 15 and 29 and 2) to compare the efficacy of
      azithromycin vs. doxycycline for treatment of rectal CT in MSM based on microbiologic cure at
      Day 15.
    

Intervention name(s): Azithromycin; Doxycycline; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.; Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.; Azithromycin placebo (4 capsules), administered orally as a single dose; Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
Intervention MeSH terms: Azithromycin; Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Azithromycin; Doxycycline; Efficacy; MSM; Phase 4; Rectal Chlamydia