Azithromycin Reduction to Reach Elimination of Trachoma

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Trachoma
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Brief Title

Azithromycin Reduction to Reach Elimination of Trachoma

Official Title

Azithromycin Reduction to Reach Elimination of Trachoma

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.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Ocular chlamydia measured in a population-based sample of 0-9 year-old children

Secondary Outcome

 Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia

Condition

Trachoma

Intervention

Azithromycin

Study Arms / Comparison Groups

 Azithromycin Continuation
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

100000

Start Date

May 29, 2021

Completion Date

January 31, 2027

Primary Completion Date

October 31, 2026

Eligibility Criteria

        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

All

Ages

1 Month - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Catherine Oldenburg, ScD, MPH, (415) 502-8843, [email protected]

Location Countries

Niger

Location Countries

Niger

Administrative Informations

NCT ID

NCT04185402

Organization ID

19-28923

Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco

Collaborators

 Programme National de Santé Oculaire (PNSO)

Study Sponsor

Catherine Oldenburg, ScD, MPH, Principal Investigator, University of California, San Francisco

Verification Date

August 2022