Azithromycin Reduction to Reach Elimination of Trachoma

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 1, 2023

Interventions

  • Drug: 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. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.

Arms, Groups and Cohorts

  • Active Comparator: Azithromycin Continuation
    • 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).
  • No Intervention: Azithromycin Discontinuation
    • In study communities randomized to the Azithromycin Discontinuation arm, individuals will receive no treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Ocular chlamydia measured in a population-based sample of 0-9 year-old children
    • Time Frame: 36 months
    • Assessed by PCR

Secondary Measures

  • Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
    • Time Frame: 36 months
    • Assessed by PCR
  • Conjunctival inflammation
    • Time Frame: 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.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 1 Month

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • Programme National de Santé Oculaire (PNSO)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Catherine Oldenburg, ScD, MPH, Principal Investigator, University of California, San Francisco
    • Tom Lietman, MD, Principal Investigator, University of California, San Francisco
    • Ariana Austin, MS, Study Director, University of California, San Francisco
  • Overall Contact(s)
    • Catherine Oldenburg, ScD, MPH, (415) 502-8843, catherine.oldenburg@ucsf.edu

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