Azithromycin Reduction to Reach Elimination of Trachoma

checkorphan
Learn more about:
Trachoma
Related Clinical Trial
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs ) Azithromycin Reduction to Reach Elimination of Trachoma Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis Modified Instrumentation for Surgery to Correct Trichiasis Smartphone App for Taking Images of Conjunctivae Water Uptake for Health in Amhara Pilot A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin Safety and Immunogenicity of a Chlamydia Vaccine CTH522 Fluorometholone as Ancillary Therapy for TT Surgery Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger Trachoma Elimination Follow-up Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger Azithromycin in Control of Trachoma II Sanitation, Water, and Instruction in Face-washing for Trachoma I/II Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders Trachoma Elimination Study by Focused Antibiotic (TESFA) Kebele Elimination of Trachoma for Ocular Health A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial Testing Insect Repellents Against Musca Sorbens, the Vector of Trachoma Trachoma Amelioration in Northern Amhara (TANA) Tripartite International Research for the Elimination of Trachoma Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania Partnership for Rapid Elimination of Trachoma Nepal Elimination of Trachoma Study Study of Three Alternatives for Mass Treatment in Trachoma Villages of Tanzania

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 27, 2021

Completion Date

October 31, 2024

Primary Completion Date

July 31, 2024

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

May 2021