Azithromycin Reduction to Reach Elimination of Trachoma (ARRET)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Trachoma

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04185402

5UG1EY030833 (U.S. NIH Grant/Contract)

19-28923

Details and patient eligibility

About

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.

Enrollment: 74,920 patients

Sex: All

Ages: 1+ month old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74,920 participants in 2 patient groups

Azithromycin Continuation

Active Comparator group

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).

Treatment:

Drug: Azithromycin

Azithromycin Discontinuation

No Intervention group

Description:

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