CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,931 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/NCT04185402
NCT04185402Phase 4Completed
CompareCT.gov

Azithromycin Reduction to Reach Elimination of Trachoma

University of California, San Francisco·interventional·Posted Dec 4, 2019·Updated Mar 25, 2026

In Brief

A Phase 4 clinical trial evaluating Azithromycin for Trachoma. Completed, enrolled 3,931 participants across 1 site.

Detailed Summary

The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maradi, Niger. The investigators will randomize communities with up to 20% Trachomatous Inflammation - Follicular (TF) prevalence following at least 5 years of mass azithromycin distribution to discontinuation or continuation of 3 additional years of annual mass azithromycin distribution.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrachoma
CountriesNiger
CollaboratorsProgramme National de Santé Oculaire (PNSO), National Eye Institute (NEI)

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 4, 2019
Enrollment StartMay 29, 2021
Primary CompletionDec 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.6 years ago

Interventions

Azithromycindrug

In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.