NCT00322972

Trachoma Amelioration in Northern Amhara (TANA)

Eliminating Trachoma With Repeat Mass Drug Treatment

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33,000 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

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.

Detailed description

The proposed study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. We will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus. Communities in Goncha Siso Enese district of East Gojam Zone, Ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research questions: Specific Aim 1. To determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments. Specific Aim 2. To determine whether children form a core group for the transmission of trachoma. Specific Aim 3. To determine whether latrine construction prevents the return of infection into a community after mass treatment. Specific Aim 4. To determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus and the reduction in mortality. Specific Aim 5. To determine whether annual mass treatments are more likely to eliminate ocular chlamydia from hyper-endemic communities than biennial mass treatments.

Conditions

• Trachoma
• Chlamydia

Interventions

Type	Name	Description
DRUG	Mass treatment with oral azithromycin to an entire community	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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-11-01
• Completion: 2014-05-01
• First posted: 2006-05-09
• Last updated: 2015-09-09

Locations

1 site across 1 country: Ethiopia