Kebele Elimination of Trachoma for Ocular Health

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Brief Title

Kebele Elimination of Trachoma for Ocular Health

Official Title

Kebele Elimination of Trachoma for Ocular Health

Brief Summary

      The investigators propose a cluster-randomized clinical trial to determine whether an
      intensive, targeted azithromycin distribution strategy is effective for elimination of
      trachoma at the kebele level compared to the World Health Organization (WHO) recommendation
      of annual azithromycin distribution.

Detailed Description

      The investigators propose to randomize at the kebele level, which consist of approximately 15
      villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be
      randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines
      (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all
      children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus
      quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR
      test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted
      treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed
      from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular
      chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load
      of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma
      assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36
      months.

Study Phase

Phase 4

Study Type

Interventional

Primary Outcome

Ocular chlamydia measured in a population based age-stratified sample of the entire community

Secondary Outcome

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

Condition

Trachoma

Intervention

Azithromycin

Study Arms / Comparison Groups

 WHO-recommended
Description:  Annual mass azithromycin distribution of all residents

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

320000

Start Date

September 1, 2021

Completion Date

September 1, 2025

Primary Completion Date

September 1, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  All individuals in all communities will be eligible for annual mass azithromycin
             distribution per WHO guidelines.

        Exclusion Criteria:

          -  Those who do not consent.

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Tom M Lietman, MD, 415-502-2662, [email protected]

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations

NCT ID

NCT03335072

Organization ID

17-22201

Secondary IDs

1UG1EY028088

Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco

Collaborators

 National Eye Institute (NEI)

Study Sponsor

Tom M Lietman, MD, Principal Investigator, University of California, San Francisco

Verification Date

May 2021