Partnership for Rapid Elimination of Trachoma (PRET)

June 19, 2017 updated by: Johns Hopkins University

Research to Programs for Trachoma Elimination: Antibiotic Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 7HT
        • London School of Hygiene and Tropical Medicine
  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF Proctor Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ≥90% coverage with azithromycin target
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Comparison of community coverage rate
Other Names:
  • Zithromax
Drug: Azithromycin
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Names:
  • Zithromax
Active Comparator: 80%-89% coverage with azithromycin target
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Comparison of community coverage rate
Other Names:
  • Zithromax
Drug: Azithromycin
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Names:
  • Zithromax
Active Comparator: ≥90% coverage with azithromycin , treatment based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.
Drug: Azithromycin
Comparison of community coverage rate
Other Names:
  • Zithromax
Drug: Azithromycin
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Names:
  • Zithromax
Active Comparator: 80%-89% coverage with azithromycin : treatment based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, treatment will be every 6-months for children ages twelve and under.
Drug: Azithromycin
Comparison of community coverage rate
Other Names:
  • Zithromax
Drug: Azithromycin
Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Names:
  • Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at Baseline
Time Frame: At baseline

Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.

The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.
At baseline
Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months
Time Frame: 3 years

100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.

50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.

Outcomes are reported at the community level because raw data could not be accessed.

There is no way to determine how many participants were examined in each arm.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Bill and Melinda Gates Foundation

Investigators

  • Principal Investigator: Sheila West, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00018439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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