Trachoma Amelioration in Northern Amhara (TANA)

Phase 4

Completed

• Conditions: Trachoma; Chlamydia
• Interventions: Drug: Mass treatment with oral azithromycin to an entire community

• Registration Number: NCT00322972
• Lead Sponsor: University of California, San Francisco

Brief 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.

Study Timeline

• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-09
• Study Start: 2006-06
• Primary Completion: 2009-11
• Study Completion: 2014-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-05
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33000

Inclusion Criteria

• All residents residing in the state-teams which are randomly selected for this study.

Exclusion Criteria

• Pregnant women
• Children under 6 months of age
• All those who are allergic to macrolides or azalides
• Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Individuals in these three exclusion criteria will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Mass treatment with oral azithromycin to an entire community	Annual mass treatment
G	Mass treatment with oral azithromycin to an entire community	One-time mass administration of antibiotics, plus intensive latrine construction
C	Mass treatment with oral azithromycin to an entire community	Mass administration of antibiotic; treatment of children (1-10 years of age) only
B	Mass treatment with oral azithromycin to an entire community	Biannual mass treatment
F	Mass treatment with oral azithromycin to an entire community	One-time mass administration only

Primary Outcome Measures

Name	Time	Method
The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3)	42 months

Secondary Outcome Measures

Name	Time	Method
Diversity measure in the conjunctival and nasopharyngeal microbiomes of children (age 0-9)	0, 6, 12, 18, 24, 30, 36, 42, and 48 months
Childhood (>= 1 year of age) mortality, analyzed as 1-5, 6-10 years of age, and total	42 months
Average prevalence of ocular chlamydia infection in annually and biennially treated communities as determined by pooled NAAT (Nucleic Acid Amplification Test)	48 months
Clinical active trachoma in community, as determined by the WHO simplified grading system	42 months
Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit)	42 months

Trial Locations

Locations (1)

Carter Center, Ethiopia; 🇪🇹 Addis Ababa, Ethiopia