NCT00221364

Trachoma Elimination Follow-up

Trachoma Elimination With Repeated Mass Azithromycin Treatments

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20,000 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment.

Detailed description

40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community.

Conditions

• Trachoma
• Chlamydia

Interventions

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

Timeline

• Start date: 2003-03-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2005-09-22
• Last updated: 2015-07-15

Locations

1 site across 1 country: Ethiopia