Partnership for Rapid Elimination of Trachoma

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Brief Title

Partnership for Rapid Elimination of Trachoma

Official Title

Research to Programs for Trachoma Elimination: Antibiotic Trial

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 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.
    

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 mass treatment.

      In The Gambia and Tanzania, communities will be further randomized to yearly mass treatment
      versus mass treatment at baseline followed by yearly mass treatment only if trachoma
      prevalence in sentinel children is greater than 5%. The communities will continue to be
      followed and treatment will resume if trachoma prevalence is found to be 20% or greater at
      the 12 or 18 month surveys.

      In Niger, communities will be randomized to the different coverage levels for annual mass
      azithromycin distribution and further randomized to biannual treatment at the two coverage
      targets for children ages twelve or younger.

      Cross-sectional rates of trachoma and infection will be determined by examining sentinel
      children, age five years or younger, randomly selected from each community based on a
      community census. The census will be updated each year, and villages will be monitored at
      baseline, 6, 12, 18, 24, 30, and 36 months for infection and clinical disease.

      The three-year study is in accord with the WHO guidelines which recommend three years of
      annual mass treatment followed by a re-survey to determine need for further treatment. The
      investigators will evaluate the efficacy of guiding further mass treatment according to a
      laboratory test for Chlamydia or WHO guidelines. Where investigators estimate communities
      have infection rates less than 5% in sentinel children, or trachomatous inflammation (TF) (
      rates less than 5%, the community will be "graduated" from further mass treatment and
      followed for up to three years to look for evidence of re-emergent infection and disease. If
      rates of infection are found to be 20% or more return at the 12 or 18 month survey, mass
      treatment will be re-initiated.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline


Condition

Trachoma

Intervention

Azithromycin

Study Arms / Comparison Groups

 ≥90% coverage with azithromycin target
Description:  Selected communities will receive mass treatment annually for three years.

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

128

Start Date

May 2008

Completion Date

June 2014

Primary Completion Date

June 2013

Eligibility 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.
      

Gender

All

Ages

N/A - 5 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sheila West, PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00792922

Organization ID

NA_00018439


Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 Bill and Melinda Gates Foundation

Study Sponsor

Sheila West, PhD, Principal Investigator, Johns Hopkins University


Verification Date

June 2017