CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 33,000 enrolled
Drug / intervention
Mass treatment with oral azithromycin to an entire communitydrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00322972
NCT00322972Phase 4Completed
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Eliminating Trachoma With Repeat Mass Drug Treatment

University of California, San Francisco·interventional·Posted May 9, 2006·Updated Sep 9, 2015

In Brief

A Phase 4 clinical trial evaluating Mass treatment with oral azithromycin to an entire community for Trachoma and Chlamydia. Completed, enrolled 33,000 participants across 1 site.

Detailed Summary

The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrachoma, Chlamydia
CountriesEthiopia
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 9, 2006
Enrollment StartJun 1, 2006
Primary CompletionNov 1, 2009
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.1 years ago

Interventions

Mass treatment with oral azithromycin to an entire communitydrug

For baseline and follow-up surveys prior to azithromycin distribution, a stratified random sample from two age groups will be chosen: 1) 60 study participants younger than 10 years old and 2) 60 study participants aged 10 years and above. Clinical examination will be performed and conjunctival swabs will be taken from all the study participants. For study arm C and D, nasopharyngeal swabs will be collected from 10 randomly selected children among the 60 participants under 10 who were recruited for conjunctival swabbing. Then a single dose of azithromycin will be distributed according to study design: in tablet form for adults; a weight-adjusted tablet dose for children ages 8-10; and pediatric suspension for children ages 1 - 7.