CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 567 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00980148
NCT00980148Phase 3Completed

Randomized Clinical Trial Evaluating Treatment Failure Following Recommended Therapy (Azithromycin Versus Doxycycline) for Genital Chlamydial Infection in Males and Females in Youth Correctional Facilities

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Sep 18, 2009·Updated Mar 18, 2015

In Brief

A Phase 3 clinical trial evaluating Azithromycin and Doxycycline for Chlamydial Infection. Completed, enrolled 567 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.8 years ago

Interventions

Azithromycindrug

FDA approved, a 1 gm single dose, two 500 mg tablets.

Doxycyclinedrug

FDA approved, a 100 mg capsule twice a day for 7 days.