Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Thomas Lietman
Headshot of Thomas Lietman
Thomas Lietman

Description

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.

Details

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.

Keywords

Trachoma, Azithromycin, Mass Drug Administration, Antibiotic Resistance, WHO-recommended

Eligibility

You can join if…

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

You CAN'T join if...

  • Those who do not consent.

Locations

  • UCSF Proctor Foundation in progress, not accepting new patients
    San Francisco California 94143 United States
  • Eyu-Ethiopia accepting new patients
    Bahir Dar Ethiopia

Lead Scientist at UCSF

  • Thomas Lietman
    Professor, Proctor Foundation, Chancellor/EVC/FAS. Authored (or co-authored) 416 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03335072
Phase
Phase 4 Trachoma Research Study
Study Type
Interventional
Participants
Expecting 320000 study participants
Last Updated