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Trachoma Elimination Study by Focused Antibiotic (TESFA)

NCT03523156 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-07-16

No results posted yet for this study

Summary

The study population consists of all households residing in eligible kebeles (sub-districts) within districts in Amhara National Regional State which are identified as having a high prevalence of trachoma and infection measured from recent trachoma impact assessments. Within each study kebele, one village will be randomly selected to serve as the sentinel study site for that kebele. Once these villages are chosen, the study team will use government-provided census records, or perform a census in each village, and will randomly choose 50 children to serve as the sentinel children for the study. After the baseline visit, all kebeles will be randomized into one of the two treatment arms to either receive standard-or-care treatment, which is an annual community-wide mass drug administration (MDA), or the enhanced antibiotic treatment. Recruitment will take place at the selected children's household. Oral informed consent will be sought from village leader/chairmen before surveys are conducted in a village. Oral informed consent will then be obtained from household heads of those houses included in the study; and then from each participating individual. Oral consents will be obtained given the low literacy rates in rural Amhara.

Data collection will occur at baseline, week 4, month 12, and month 24 in both arms of the study. A head of household will be asked a series of household level questions, which will be followed by a household-level census, where all consenting participants residing in the selected households will have their eyes examined for trachoma signs. This is a non-invasive procedure whereby a trained trachoma grader flips each eyelid and examines for trachoma signs. Lastly, the selected child and one randomly selected adult will have their right eye lid swabbed for evidence of trachoma infection. The total estimated respondent burden is 30 to 45 minutes.

Conditions

  • Trachoma

Interventions

DRUG

Azithromycin mass treatment

Standard of care annual community-wide mass drug administration (MDA) will be provided at the normally scheduled time.

DRUG

Azithromycin targeted treatment

Two rounds of treatment targeted to all children aged 2 to 9 years old. The first targeted round will be 1-2 weeks after the community-wide MDA and the second round will occur another 1-2 weeks later.

Sponsors & Collaborators

  • The Carter Center

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Kelly Callahan, MPH · The Carter Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-04-30
Completion
2027-04-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523156 on ClinicalTrials.gov