Trial | NCT04185402  Report issue

Official Title

Azithromycin Reduction to Reach Elimination of Trachoma

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    100000
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 Started
May 29
2021
Primary Completion
Oct 31
2026
Anticipated
Study Completion
Jan 31
2027
Anticipated
Last Update
Aug 16
2023

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.

Azithromycin Continuation Active Comparator

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. Oral azithromycin, 20 mg/kg for children and 1 g for adults, will be offered to all households identified on the preceding census in the communities randomized to continuing treatment. Study drug will be distributed by health extension workers and organized by PNSO. Individuals with a known macrolide allergy will be offered a two-week course of daily ophthalmic tetracycline ointment (two tubes).

Azithromycin Discontinuation No Intervention

In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.

Criteria 

Inclusion Criteria:

Provision of appropriate informed consent
Stated willingness to comply with all study procedures
Live in one of the 80 communities with up to 20% prevalence of TF selected for the trial

Exclusion Criteria:

Does not consent to participation
Unwilling to comply with all study procedures
Does not live in one of the 80 communities with up to 20% prevalence of TF selected for the trial
No Results Posted