NCT01202331

Tripartite International Research for the Elimination of Trachoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29,000 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

Summary

Mass antimicrobial administrations have been remarkably successful in reducing the prevalence of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively lower the prevalence of infection, and in some cases may even result in local elimination. Mass treatments cannot be continued forever, due to concerns about cost and antibiotic resistance. The hope has been that other measures such as latrine construction and hygiene programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has yet demonstrated an effect on infection. 1. We hypothesize that Chlamydial infection will return to communities when treatment ends. 2. We hypothesize that infection will be completely eliminated in all communities treated for seven years. 3. We hypothesize that identifying and treating clinically active cases among preschool aged children will delay or even prevent reemergence at a far lower cost than mass treatment of all individuals.

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 continue to monitor a sub-set of communities from our TANA study, in Goncha Siso Enese district of East Gojam Zone, Ethiopia. Here we evaluate how infection returns when antibiotics are discontinued, whether infection can be predictably eliminated, and whether infection can be prevented from returning with targeted treatment strategies: Specific Aim 1. To determine whether antibiotics can be stopped after 4 years. Specific Aim 2. To determine whether infection can be completely eliminated if mass treatments continue for seven years. Specific Aim 3. To determine whether treatment targeted to pre-school aged children, or to households in which a pre-school aged child has clinically active trachoma, will prevent infection from returning into the community. Specific Aim 4: To determine whether mass azithromycin distributions reduce visits to local health clinics due to all causes and infectious causes. Specific Aim 5: To determine whether mass azithromycin distributions result in better growth metrics (weight-for-height, height-for age, weight-for-age, middle upper arm circumference) compared to no treatment. Specific Aim 6: To determine whether under-5 mortality is lower in communities treated with mass azithromycin compared to no treatment Specific Aim 7: To determine whether macrolide resistance in Streptococcus pneumoniae, Hameophilus influenzae, and Staphylococcus aureus is more prevalent in communities treated with biannual mass azithromycin compared to communities treated with annual mass azithromycin, and to determine whether targeted azithromycin treatments result in less macrolide resistance compared to mass azithromycin distributions.

Conditions

• Trachoma
• Chlamydia

Interventions

Type	Name	Description
DRUG	mass treatment with oral azithromycin	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. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 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: 2010-11-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2010-09-15
• Last updated: 2017-10-11

Locations

1 site across 1 country: Ethiopia