Kebele Elimination of Trachoma for Ocular Health (KETFO)

The investigators propose a cluster-randomized clinical trial to determine whether an intensive, targeted azithromycin distribution strategy is effective for elimination of trachoma at the kebele level compared to the World Health Organization (WHO) recommendation of annual azithromycin distribution.

Study Overview

• Status: Recruiting
• Conditions: Trachoma
• Intervention / Treatment: Drug: Azithromycin

Detailed Description

The investigators propose to randomize at the kebele level, which consist of approximately 15 villages, 4,000 residents, and are served by a single primary school. Eighty kebeles will be randomized to one of four arms: 1) annual mass azithromycin distribution per WHO guidelines (Annual); 2) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years (Core Group-Age); 3) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years with a positive chlamydial PCR test (Core Group-PCR); or 4) annual mass azithromycin distribution plus quarterly targeted treatment of all children aged 0-9 years positive for conjunctival inflammation as assessed from annual photography (Core Group-TI). The primary outcome for the trial will be the ocular chlamydia prevalence at 12, 24, and 36 months. Secondary outcomes will include bacterial load of ocular chlamydia via quantitative PCR, the prevalence of clinically active trachoma assessed at 12, 24, and 36 months, and serology via dried blood spot at baseline and 36 months.

• Study Type: Interventional
• Enrollment (Estimated): 320000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hadley Burroughs, MSPH; Phone Number: 415-476-1442; Email: Hadley.burroughs@ucsf.edu
• Study Contact Backup: Name: Tom M Lietman, MD; Phone Number: 415-502-2662; Email: Tom.Lietman@ucsf.edu

Study Locations

• Ethiopia
  • Bahir Dar, Ethiopia
    • Recruiting
    • Eyu-Ethiopia
    • Contact: Esmael Habtamu Ali, PhD
• United States
  • California
    • San Francisco, California, United States, 94143
      • Active, not recruiting
      • UCSF Proctor Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All individuals in all communities will be eligible for annual mass azithromycin distribution per WHO guidelines.

Exclusion Criteria:

• Those who do not consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: WHO-recommended; Annual mass azithromycin distribution of all residents	Drug: Azithromycin; Mass Drug Administration; Other Names: Zithromax
Experimental: Age-based core group; Annual mass azithromycin treatment of everyone plus quarterly treatment of children	Drug: Azithromycin; Mass Drug Administration; Other Names: Zithromax
Experimental: PCR infection-based core group; Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.	Drug: Azithromycin; Mass Drug Administration; Other Names: Zithromax
Experimental: TI-based core group; Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group	Drug: Azithromycin; Mass Drug Administration; Other Names: Zithromax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular chlamydia measured in a population based age-stratified sample of the entire community	Assessed by PCR	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia	Assessed by PCR	36 months
Conjunctival inflammation	Assessed from conjunctival photography	36 months
Seropositivity to C. trachomatis antibodies CT694 and Pgp3	Assessed via ELISA on elute from dried blood spots	36 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Eye Institute (NEI); Bahir Dar University; Eyu-Ethiopia
• Investigators: Study Director: Hadley Burroughs, MSPH, University of California, San Francisco; Principal Investigator: Tom M Lietman, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 3, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Azithromycin; Antibiotic Resistance; Mass Drug Administration
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctivitis; Conjunctival Diseases; Corneal Diseases; Chlamydiaceae Infections; Eye Infections, Bacterial; Eye Infections; Chlamydia Infections; Conjunctivitis, Bacterial; Trachoma; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 17-22201; 1UG1EY028088 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes