NCT06289647

Azithromycin Reduction to Reach Elimination of Trachoma B

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Month – 9 Years
• Healthy volunteers: Accepted

Summary

The investigators propose a randomized controlled trial of discontinuation versus continuation of annual mass azithromycin distribution in hypoendemic communities of Maniema, DRC. 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

Type	Name	Description
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2029-08-31
• Completion: 2029-08-31
• First posted: 2024-03-04
• Last updated: 2026-03-13

Locations

1 site across 1 country: Democratic Republic of the Congo

Regulatory

• FDA-regulated drug study