NCT03335072

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
320,000

participants targeted

Target at P75+ for phase_4

Timeline
23mo left

Started Feb 2022

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Feb 2022Mar 2028

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
4.3 years until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

5.1 years

First QC Date

November 3, 2017

Last Update Submit

October 21, 2025

Conditions

Trachoma

Keywords

AzithromycinMass Drug AdministrationAntibiotic Resistance

Outcome Measures

Primary Outcomes (1)

  • Ocular chlamydia measured in a population based age-stratified sample of the entire community

    Assessed by PCR

    36 months

Secondary Outcomes (2)

  • Infectious load of chlamydia among 0-9 year-old children infected with ocular chlamydia

    36 months

  • Conjunctival inflammation

    36 months

Study Arms (4)

WHO-recommended

ACTIVE COMPARATOR

Annual mass azithromycin distribution of all residents

Drug: Azithromycin

Age-based core group

EXPERIMENTAL

Annual mass azithromycin treatment of everyone plus quarterly treatment of children

Drug: Azithromycin

PCR infection-based core group

EXPERIMENTAL

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

TI-based core group

EXPERIMENTAL

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

Interventions

AzithromycinDRUG

Mass Drug Administration

Also known as: Zithromax
Age-based core groupPCR infection-based core groupTI-based core groupWHO-recommended

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Those who do not consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCSF Proctor Foundation

San Francisco, California, 94143, United States

Location

Eyu-Ethiopia

Bahir Dar, Ethiopia

Location

MeSH Terms

Conditions

Trachoma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, BacterialEye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsChlamydia InfectionsChlamydiaceae InfectionsGram-Negative Bacterial InfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye DiseasesCorneal Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Tom M Lietman, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Hadley Burroughs, MSPH

    University of California, San Francisco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

February 7, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 23, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)ET(1)