CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 100 enrolled
Drug / intervention
Azithromycindrug
Likely dose
Not stated in 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/NCT03249935
NCT03249935Phase 2Completed

Treatment Failure and Associated Predictors Following Azithromycin Treatment for Urogenital Chlamydial Infection in Males in Youth Correctional Facilities

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 15, 2017·Updated Oct 28, 2019

In Brief

A Phase 2 clinical trial evaluating Azithromycin for Chlamydial Infection. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 15, 2017
Enrollment StartAug 24, 2017
Primary CompletionSep 17, 2018
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.9 years ago

Interventions

Azithromycindrug

Azithromycin 1 gm PO single dose given as directly observed