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

Health Conditions
  • Trachoma
Completed
Recruitment Status
NCT00792922
Primary Trial ID Number
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.
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
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United States; United Kingdom
Participant Sex
Both
Participant Age Range
N/A to 12 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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.
Interventions
Drug; Azithromycin; Comparison of community coverage rate; [≥90% coverage target, 80%-89% coverage target]; 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.; [≥90% coveage, treatment based, 80%-89% coverage: treatment based]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Results Reporting
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Acronym
PRET
Scientific Title
Research to Programs for Trachoma Elimination: Antibiotic Trial
Secondary Trial Identifying Number
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Website
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Study Funded By
Johns Hopkins University
Funder Type
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Study Sponsored By
Johns Hopkins University
Study Also Sponsored By
Bill and Melinda Gates Foundation
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

17 Nov 2008

Last Updated

06 Apr 2015

Date Record Refreshed on UKCTG

31 Jul 2015