Partnership for Rapid Elimination of Trachoma | Completed
Partnership for Rapid Elimination of Trachoma
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Trachoma
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
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.
Research Details
  • 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. We will evaluate the efficacy of guiding further mass treatment according to a laboratory test for Chlamydia or WHO guidelines. Where we estimate communities have infection rates less than 5% in sentinel children, or 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.
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Study Type
Drug : Azithromycin, Drug : Azithromycin

Study Arm Groups : ≥90% coverage target, 80%-89% coverage target, ≥90% coveage, treatment based, 80%-89% coverage: treatment based

Intervention Type
See Interventions above
Primary Outcome Measures
  • Community prevalence of trachoma and ocular C. trachomatis infection; 5 years
Secondary Outcome Measures
  • Community costs of mass treatment; 5 years; Community costs of incident infection; 5 years; Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit); 36 months; Anthropometric measurements (WHZ, WAZ, HAZ, MUACZ), as outlined by WHO child growth standards (0-5 years of age); 12-36 months after baseline; Prevalence of anemia (hemoglobin levels in 0-5 year olds) and the prevalence of malaria; 12 - 36 months after baseline; Mortality in 1-5 year old study children; Over study period; Cause-specific mortality in 1-5 year olds assessed by verbal autopsy; Over study period; Mortality in adults in the study area; Over study period; Cause-specific mortality in adults assessed by verbal autopsy; Over study period; Morbidity among 1-5 year old study children as assessed by height for age, weight for age, weight for height, body mass index and Hackett spleen size; 30 months after baseline; Serotype distribution, antibiotic sensitivity profile and MLST type of Streptococcus pneumoniae carried in the nasopharynx of study children; 30 months after baseline; Rates of health clinic visits overall, for infectious diseases, diarrhea, malaria, respiratory disease, and antibiotics distributed; 12, 24, and 36 months after baseline; Mortality in children; Over study period; Mortality in adults; Over study period
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
N/A - 12 Years
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion criteria for communities:
  • 1. Communities are located in the target districts and accessible by vehicle
  • 2. The community leaders consent to have the community enrolled
  • 3. Rapid assessment and/or available data suggest trachoma rates are higher than 20% in
  • the community.
  • 4. 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:
  • 1. The child is age 5 years or younger
  • 2. 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).
  • 3. The child must not have an ocular condition that would preclude grading trachoma or
  • taking an ocular specimen.
  • 4. 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)
  • 5. The child must have an identifiable guardian capable of providing consent to
  • participate.
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
London School of Hygiene and Tropical Medicine
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom, United States
Scientific Title
Research to Programs for Trachoma Elimination: Antibiotic Trial
EudraCT Number
Not available for this trial
  • Bill and Melinda Gates Foundation
Other Study ID Numbers
Johns Hopkins University
Key Dates

Recruitment Start Date

May 2008

Recruitment End Date

Jun 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

17 Nov 2008

Last Updated

06 Apr 2015