Partnership for Rapid Elimination of Trachoma

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes the use of antibiotic treatment to reduce the community pool of infection with C. trachomatis. The objective of this study is to conduct a randomized, community-based trial in three countries (Niger, Tanzania and The Gambia), representing different baseline endemicities, of alternative coverages and frequencies of administration of mass antibiotic treatment as well as to determine the cost-effectiveness of these different strategies from a program perspective.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Bill and Melinda Gates Foundation
• Treatments: Azithromycin

Criteria

Inclusion criteria for communities:

• Communities are located in the target districts and accessible by vehicle

• The community leaders consent to have the community enrolled

• Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.

• The community size is <5,000 persons or >250 persons.

If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:

• The child is age 5 years or younger

• The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).

• The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.

• The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)

• The child must have an identifiable guardian capable of providing consent to participate.