Trachoma Clinical Trial
— ARRETOfficial title:
Azithromycin Reduction to Reach Elimination of Trachoma
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.
Status | Recruiting |
Enrollment | 100000 |
Est. completion date | October 31, 2026 |
Est. primary completion date | October 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Niger | Programme National de Santé Oculaire (PNSO) | Niamey |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Eye Institute (NEI), Programme National de Santé Oculaire (PNSO) |
Niger,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular chlamydia measured in a population-based sample of 0-9 year-old children | Assessed by PCR | 36 months | |
Secondary | Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia | Assessed by PCR | 36 months | |
Secondary | Conjunctival inflammation | Assessed from conjunctival photography. Clinical photographs of the conjunctiva will be assessed by masked graders according to the grading scale described by the WHO Simplified Grading System. | 36 months |
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