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NCT00980148 · ClinicalTrials.gov registry record · Phase 3
Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities
A Phase 3 study of Chlamydial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 567
- Enrollment target
- 2
- Study locations
NCT00980148: Completed Phase 3 study of Chlamydial Infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00980148 is a Phase 3 study of Chlamydial Infection that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 567 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00980148, a Phase 3 study of Chlamydial Infection, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 567 participants
- Enrollment target
- 2
- Study locations
Study Summary
Chlamydia is a common infection among youth and can be given from one person to another during sex. Many people who have chlamydia have no signs of infection at all, but can pass the infection to anyone they have sex with. If not treated, chlamydia can lead to serious health problems. This study will look at how well medicines given for chlamydia infection work. The study requires 306 evaluable subjects, chlamydia-positive, males and non-pregnant females, ages 12-21, living in long-term, gender-segregated youth correctional facilities. Participants will be assigned to receive either doxycycline (2 times per day, by mouth, for 7 days) or azithromycin (1 single dose by mouth). Study procedures will include collection of at least 3 urine samples to test for chlamydia. Study visits will occur during initial enrollment in the study, day 28 after starting treatment, and day 67. Participants will be involved in study related procedures for up to 67 days.
Primary Outcome
The proportion of participants with testing by Gen-Probe Aptima Combo 2 that is positive for C. trachomatis and C. trachomatis OmpA (Major Outer Membrane Protein) genotyping reveals the baseline chlamydial strain and the repeat positive chlamydial strain to be the same genotype (i.e., concordant).
Conditions Studied
Interventions
- DRUG Azithromycin
- DRUG Doxycycline
Study Locations (2)
Alabama
- University of Alabama Hospital - Infectious Diseases - Birmingham
California
- Los Angeles County Department of Public Health - Sexually Transmitted Disease Program - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 567 participants |
| Start Date | 2009-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
What the finished NCT00980148 record still lists
NCT00980148 is an interventional study that assigns participants to a tested intervention. The registered 567 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Chlamydial Infection appearing as the primary indexed condition, and to 2 interventions - of which Azithromycin is the first listed.
NCT00980148 reports a single indexed study location in Alabama, California.
Frequently Asked Questions
What is clinical trial NCT00980148 about?
NCT00980148 is a clinical study titled "Treatment Failure of Chlamydial Infection in Males and Females in Youth Correctional Facilities". Chlamydia is a common infection among youth and can be given from one person to another during sex. Many people who have chlamydia have no signs of infection at all, but can pass the infection to anyone they have sex with. If not treated, chlamydia can lead to serious health problems. This study wil...
What is the current status of trial NCT00980148?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 567 participants. The study started on 2009-12. Estimated completion is 2014-05.
What conditions does trial NCT00980148 study?
This clinical trial studies the following conditions: Chlamydial Infection.
What interventions are being tested in trial NCT00980148?
The interventions under investigation include: Azithromycin (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT00980148?
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 NCT00980148 being conducted?
This trial has 2 study locations across Alabama, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00980148's enrollment target sits among peer trials
567 667th of 2000 higher than 1,334 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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