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NCT03608774 · ClinicalTrials.gov registry record · Phase 4
Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM
A Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 177
- Enrollment target
NCT03608774: Completed Phase 4 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03608774 is a Phase 4 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 177 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03608774, a Phase 4 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 177 participants
- Enrollment target
Study 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.
Primary Outcome
Microbiologic cure was based on rectal CT (Chlamydia trachomatis) NAAT (nucleic acid amplification test) result. The proportion of subjects with microbiologic cure in each study arm at Day 29 is reported in this outcome measure.
Interventions
- OTHER Placebo
- DRUG Azithromycin
- DRUG Doxycycline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 177 participants |
| Start Date | 2018-07-13 |
| Est. Completion | 2020-02-21 |
| Phase | Phase 4 |
What the finished NCT03608774 record still lists
NCT03608774 is an interventional study that assigns participants to a tested intervention. The registered 177 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03608774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03608774 about?
NCT03608774 is a clinical study titled "Trial of Azithromycin vs. Doxycycline for the Treatment of Rectal Chlamydia in MSM". 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 ...
What is the current status of trial NCT03608774?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 177 participants. The study started on 2018-07-13. Estimated completion is 2020-02-21.
What interventions are being tested in trial NCT03608774?
The interventions under investigation include: Placebo (OTHER), Azithromycin (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT03608774?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03608774's enrollment target sits among peer trials
177 477th of 2000 higher than 1,524 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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