|
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.
(from ClinicalTrials.gov)
|
|
Ethics Approval
|
Sorry, not currently available
|
|
Study Design
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
|
|
Design Type
|
Sorry, not currently available
|
|
Design Details
|
Sorry, not currently available
|
|
Health Condition(s) or Problem
|
Trachoma
|
|
Participants 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.
|
|
Participants 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.
|
|
Participant Sex
|
Sorry, not currently available
|
|
Participant Age Range
|
Sorry, not currently available
|
|
Participant Type
|
Sorry, not currently available
|
|
Target Sample Size
|
15000
|
|
Date of First Enrolment
|
Sorry, not currently available
|
|
Date of Recruitment End
|
Sorry, not currently available
|
|
Date of End of Follow-up
|
Sorry, not currently available
|
|
Trial End Date
|
Sorry, not currently available
|
|
Recruitment Status
|
Recruiting
|
|
Overall Trial Status
|
Sorry, not currently available
|
|
Countries of Recruitment
|
United States; United Kingdom
|
|
Nation
|
England
|
|
Location
|
London
|
|
Interventions
|
Drug; Azithromycin; Comparison of community coverage rate; =90% coverage target; 80%-89% coverage target; 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.; =90% coveage, treatment based; 80%-89% coverage: treatment based; Zithromax
|
|
Primary Outcome Measures
|
Community prevalence of trachoma and ocular C. trachomatis infection
|
|
Secondary Outcome Measures
|
Community costs of mass treatment; 5 years; No; Community costs of incident infection; 5 years; No; Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit); 36 months; No; PRET Niger; Anthropometric measurements (WHZ, WAZ, HAZ, MUACZ), as outlined by WHO child growth standards (0-5 years of age); 12-36 months after baseline; No; PRET Niger; Prevalence of anemia (hemoglobin levels in 0-5 year olds) and the prevalence of malaria; 12 - 36 months after baseline; No; PRET Niger; Mortality in 1-5 year old study children; Over study period; No; PRET Gambia; Cause-specific mortality in 1-5 year olds assessed by verbal autopsy; Over study period; No; PRET Gambia; Mortality in adults in the study area; Over study period; No; PRET Gambia; Cause-specific mortality in adults assessed by verbal autopsy; Over study period; No; PRET Gambia; 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; No; PRET Gambia; Serotype distribution, antibiotic sensitivity profile and MLST type of Streptococcus pneumoniae carried in the nasopharynx of study children; 30 months after baseline; No; PRET Gambia; Rates of health clinic visits overall, for infectious diseases, diarrhea, malaria, respiratory disease, and antibiotics distributed; 12, 24, and 36 months after baseline; No; PRET Niger; Mortality in children; Over study period; No; PRET Niger; Mortality in adults; Over study period; No; PRET Niger
|
|
Website
|
Sorry, not currently available
|