Kebele Elimination of Trachoma for Ocular Health (KETFO)
Primary Purpose
Trachoma
Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Trachoma focused on measuring Azithromycin, Mass Drug Administration, Antibiotic Resistance
Eligibility Criteria
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.
Sites / Locations
- UCSF Proctor Foundation
- Eyu-EthiopiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
WHO-recommended
Age-based core group
PCR infection-based core group
TI-based core group
Arm Description
Annual mass azithromycin distribution of all residents
Annual mass azithromycin treatment of everyone plus quarterly treatment of children
Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-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
Outcomes
Primary Outcome Measures
Ocular chlamydia measured in a population based age-stratified sample of the entire community
Assessed by PCR
Secondary Outcome Measures
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
Assessed by PCR
Conjunctival inflammation
Assessed from conjunctival photography
Seropositivity to C. trachomatis antibodies CT694 and Pgp3
Assessed via ELISA on elute from dried blood spots
Full Information
NCT ID
NCT03335072
First Posted
November 3, 2017
Last Updated
February 1, 2023
Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI), Eyu-Ethiopia, Bahir Dar University
1. Study Identification
Unique Protocol Identification Number
NCT03335072
Brief Title
Kebele Elimination of Trachoma for Ocular Health
Acronym
KETFO
Official Title
Kebele Elimination of Trachoma for Ocular Health
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
March 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI), Eyu-Ethiopia, Bahir Dar University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
Keywords
Azithromycin, Mass Drug Administration, Antibiotic Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WHO-recommended
Arm Type
Active Comparator
Arm Description
Annual mass azithromycin distribution of all residents
Arm Title
Age-based core group
Arm Type
Experimental
Arm Description
Annual mass azithromycin treatment of everyone plus quarterly treatment of children
Arm Title
PCR infection-based core group
Arm Type
Experimental
Arm Description
Annual mass azithromycin treatment plus quarterly treatment of a PCR-based cohort that would be a subset of the age-based core group.
Arm Title
TI-based core group
Arm Type
Experimental
Arm Description
Annual mass azithromycin treatment plus quarterly treatment of a conjunctival photography-based cohort that would be a subset of the age-based core group
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Intervention Description
Mass Drug Administration
Primary Outcome Measure Information:
Title
Ocular chlamydia measured in a population based age-stratified sample of the entire community
Description
Assessed by PCR
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia
Description
Assessed by PCR
Time Frame
36 months
Title
Conjunctival inflammation
Description
Assessed from conjunctival photography
Time Frame
36 months
Title
Seropositivity to C. trachomatis antibodies CT694 and Pgp3
Description
Assessed via ELISA on elute from dried blood spots
Time Frame
36 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom M Lietman, MD
Phone
415-502-2662
Email
Tom.Lietman@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hadley Burroughs, MSPH
Phone
415-476-1442
Email
Hadley.burroughs@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom M Lietman, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hadley Burroughs, MSPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Director
Facility Information:
Facility Name
UCSF Proctor Foundation
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Eyu-Ethiopia
City
Bahir Dar
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esmael Habtamu Ali, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Kebele Elimination of Trachoma for Ocular Health
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