Status:

COMPLETED

Partnership for Rapid Elimination of Trachoma

Lead Sponsor:

Johns Hopkins University

Collaborating Sponsors:

Bill and Melinda Gates Foundation

Conditions:

Trachoma

Eligibility:

All Genders

Up to 5 years

Phase:

PHASE4

Brief 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 cont...

Detailed Description

A randomized, 2x2 factorial designed trial will be implemented in each of the three countries. Communities will be randomized to two different coverage targets (80%-89% versus ≥90%) for three years of...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2014

    Estimated Enrollment :

    128 Patients enrolled

    Trial Details

    Trial ID

    NCT00792922

    Start Date

    May 1 2008

    End Date

    June 1 2014

    Last Update

    July 18 2017

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    UCSF Proctor Foundation

    San Francisco, California, United States, 94143

    2

    Johns Hopkins University

    Baltimore, Maryland, United States, 21205

    3

    London School of Hygiene and Tropical Medicine

    London, United Kingdom, WC1E 7HT