Azithromycin Reduction to Reach Elimination of Trachoma

Study Overview
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Brief Summary
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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.

Official Title
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Azithromycin Reduction to Reach Elimination of Trachoma

Conditions
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Trachoma

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Azithromycin Continuation<br>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). | Drug: Azithromycin<br>* 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.<br>|
| No Intervention: Azithromycin Discontinuation<br>In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular chlamydia measured in a population-based sample of 0-9 year-old children | Assessed by PCR | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia | Assessed by PCR | 36 months | 
| 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 |