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NCT03249935 · ClinicalTrials.gov registry record · Phase 2
YCFM (Youth Correctional Facilities Males)
A Phase 2 study of Chlamydial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT03249935: Completed Phase 2 study of Chlamydial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03249935 is a Phase 2 study of Chlamydial Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03249935, a Phase 2 study of Chlamydial Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study is a single center (with multiple long-term YCFs) treatment trial of the CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is designed primarily to determine the frequency of chlamydia treatment failure following azithromycin in males who do versus do not have urethral symptoms of urethral discharge and/or dysuria. Anticipated enrollment is 446 males, between the age of 12 to 21 years old, with subject participation duration of 28 days and study duration of 4 years. The primary objective of the study is to assess the microbiological efficacy of azithromycin in uncomplicated Chlamydia trachomatis infection in males with versus without urethral symptoms in YCFs.
Primary Outcome
Test positive for Chlamydia trachomatis with Aptima Combo 2® Assay (AC2) and having enrollment and follow-up CT strains that had concordant genotyping of the CT major outer membrane protein (ompA) sequences or, if genotyping was unsuccessful on urine from both visits (i.e., due to insufficient number of ompA copies), then participants could not have unsupervised furloughs or report interim sex to be categorized as a treatment failure.
Conditions Studied
Interventions
- DRUG Azithromycin
Study Locations (1)
California
- Los Angeles County Department of Health Services - Juvenile Court Health Services - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-08-24 |
| Est. Completion | 2018-09-17 |
| Phase | Phase 2 |
What the finished NCT03249935 record still lists
NCT03249935 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Chlamydial Infection appearing as the primary indexed condition, and to 1 intervention - of which Azithromycin is the first listed.
NCT03249935 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03249935 about?
NCT03249935 is a clinical study titled "YCFM (Youth Correctional Facilities Males)". The proposed study is a single center (with multiple long-term YCFs) treatment trial of the CDC-recommended azithromycin regimen (1 gm PO once) for chlamydia in males. This study is designed primarily to determine the frequency of chlamydia treatment failure following azithromycin in males who do ve...
What is the current status of trial NCT03249935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-08-24. Estimated completion is 2018-09-17.
What conditions does trial NCT03249935 study?
This clinical trial studies the following conditions: Chlamydial Infection.
What interventions are being tested in trial NCT03249935?
The interventions under investigation include: Azithromycin (DRUG).
Who is sponsoring clinical trial NCT03249935?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03249935 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03249935's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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