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Azithromycin Reduction to Reach Elimination of Trachoma

NCT04185402 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3931

Last updated 2026-03-25

Study results available
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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.

Conditions

  • Trachoma

Interventions

DRUG

Azithromycin

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.

Sponsors & Collaborators

Principal Investigators

  • Catherine Oldenburg, ScD, MPH · University of California, San Francisco

  • Tom Lietman, MD · University of California, San Francisco

  • Elodie Lebas, RN · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-29
Primary Completion
2024-12-18
Completion
2024-12-18
FDA Drug
Yes

Countries

  • Niger

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04185402 on ClinicalTrials.gov