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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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23 October 2023 |
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Main ID: |
NCT03523156 |
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Date of registration:
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01/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trachoma Elimination Study by Focused Antibiotic (TESFA)
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Scientific title:
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Trachoma Elimination Study by Focused Antibiotic (TESFA): The Impact of an Enhanced Antibiotic Treatment Regimen on Trachoma in Amhara, Ethiopia |
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Date of first enrolment:
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April 2024 |
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Target sample size:
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53384 |
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Recruitment status: |
Suspended |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03523156 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Ethiopia
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Contacts
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Name:
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Kelly Callahan, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Carter Center |
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Key inclusion & exclusion criteria
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Cluster (kebele) Inclusion Criteria:
- The kebele must be located in Amhara and eligible for annual MDA with azithromycin
under WHO treatment guidelines.
- Located within targeted districts where the prevalence of TF is high (at least 30%)
and the prevalence of CT infection is suspected to be high (10% if possible) measured
from the most recent trachoma impact assessment.
- The kebele representatives consent to participation in the trial.
Gott (village) Inclusion Criteria:
- At least 50 children residing in the gott.
Child Inclusion Criteria:
- Must reside in a cluster selected for this study.
- Must have a head of household or designated "adult-in-charge" who can provide consent
for that child to be included in the study sample and to consent to allowing study
staff to collect an ocular swab from the conjunctival epithelium.
- Child must assent to having a swab taken.
- Child must not have an ocular condition which would preclude grading trachoma or
taking an ocular specimen.
Exclusion Criteria:
- none
Age minimum:
2 Years
Age maximum:
9 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Trachoma
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Intervention(s)
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Drug: Azithromycin targeted treatment
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Drug: Azithromycin mass treatment
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Primary Outcome(s)
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Prevalence of Chlamydia trachomatis (CT) infection
[Time Frame: Month 12]
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Secondary Outcome(s)
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Prevalence of Chlamydia trachomatis (CT) infection among adults
[Time Frame: Month 12]
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Change in prevalence of trachomatous inflammation-follicular (TF)
[Time Frame: Baseline, Week 4, Month 12, Month 24]
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Cluster-level Chlamydial load
[Time Frame: Baseline, Week 4, Month 12, Month 24]
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Cost
[Time Frame: Month 24]
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Correlation between Chlamydial Infection and trachomatous inflammation-follicular (TF) and trachomatous inflammation-intense (TI)
[Time Frame: Baseline, Week 4, Month 12, Month 24]
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Cost-effectiveness
[Time Frame: Month 24]
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Change in Chlamydia trachomatis (CT) infection in children
[Time Frame: Baseline, Month 12, Month 24]
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Change in prevalence of trachomatous inflammation-intense (TI)
[Time Frame: Baseline, Week 4, Month 12, Month 24]
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Secondary ID(s)
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IRB00085779
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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