Trachoma Elimination Study by Focused Antibiotic (TESFA)

NCT03523156 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: IRB00085779
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Antibiotics; Infectious diseases; Tropical medicine; Public health

Outcome Measures

Primary Outcomes (1)

• Prevalence of Chlamydia trachomatis (CT) infection

  The community-level prevalence of CT infection in children aged 6 months to 9 years will be compared between study arms.

  Month 12

Secondary Outcomes (8)

• Change in prevalence of trachomatous inflammation-follicular (TF)

  Baseline, Week 4, Month 12, Month 24

• Change in prevalence of trachomatous inflammation-intense (TI)

  Baseline, Week 4, Month 12, Month 24

• Change in Chlamydia trachomatis (CT) infection in children

  Baseline, Month 12, Month 24

• Prevalence of Chlamydia trachomatis (CT) infection among adults

  Month 12

• Cost

  Month 24

Study Arms (2)

Azithromycin mass treatment

ACTIVE COMPARATOR

Persons living in regions randomized to this arm will receive mass drug administration (MDA) of azithromycin per the current annual MDA schedule.

Drug: Azithromycin mass treatment

Azithromycin mass treatment plus targeted treatment

EXPERIMENTAL

In addition to azithromycin administration per the current annual MDA schedule, children in regions randomized to this arm will receive azithromycin targeted treatment.

Drug: Azithromycin mass treatment; Drug: Azithromycin targeted treatment

Interventions

Azithromycin mass treatment DRUG

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

Also known as: Zithromax

Azithromycin mass treatment; Azithromycin mass treatment plus targeted treatment

Azithromycin targeted treatment DRUG

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.

Also known as: Zithromax

Azithromycin mass treatment plus targeted treatment

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• At least 50 children residing in the gott.
• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Emory University: lead
• The Carter Center: collaborator

MeSH Terms

Conditions

Trachoma; Communicable Diseases

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Kelly Callahan, MPH

  The Carter Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director

Model Details: Sixty-four kebeles (sub-districts) of Amhara will be randomized to receive annual mass treatment or annual mass treatment plus targeted treatment. One gott (village) per kebele will be selected and 50 children from each gott will be randomly selected.

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Study Start: June 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07