Azithromycin Reduction to Reach Elimination of Trachoma
- Registration Number
- NCT04185402
- Lead Sponsor
- University of California, San Francisco
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100000
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azithromycin Continuation 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. 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).
- Primary Outcome Measures
Name Time Method Ocular chlamydia measured in a population-based sample of 0-9 year-old children 36 months Assessed by PCR
- Secondary Outcome Measures
Name Time Method Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia 36 months Assessed by PCR
Conjunctival inflammation 36 months 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.
Trial Locations
- Locations (1)
Programme National de Santé Oculaire (PNSO)
🇳🇪Niamey, Niger