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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
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trachoma focused on measuring Azithromycin, Mass Drug Administration, Antibiotic Resistance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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