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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03608774
The ClinicalTrials.gov registry entry for NCT03608774 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 177 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03608774 reports 0 study locations.
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.
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