Brief Title
Azithromycin Reduction to Reach Elimination of Trachoma
Official Title
Azithromycin Reduction to Reach Elimination of Trachoma
Brief 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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
Ocular chlamydia measured in a population-based sample of 0-9 year-old children
Secondary Outcome
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
Condition
Trachoma
Intervention
Azithromycin
Study Arms / Comparison Groups
Azithromycin Continuation
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100000
Start Date
May 29, 2021
Completion Date
January 31, 2027
Primary Completion Date
October 31, 2026
Eligibility 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
Gender
All
Ages
1 Month - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Catherine Oldenburg, ScD, MPH, (415) 502-8843, [email protected]
Location Countries
Niger
Location Countries
Niger
Administrative Informations
NCT ID
NCT04185402
Organization ID
19-28923
Responsible Party
Sponsor
Study Sponsor
University of California, San Francisco
Collaborators
Programme National de Santé Oculaire (PNSO)
Study Sponsor
Catherine Oldenburg, ScD, MPH, Principal Investigator, University of California, San Francisco
Verification Date
August 2022