Nepal Elimination of Trachoma Study

Phase 2

Withdrawn

• Conditions: Trachoma
• Interventions: Drug: Azithromycin

• Registration Number: NCT02176057
• Lead Sponsor: University of California, San Francisco

Brief Summary

The main purpose of this study is to determine if ocular Chlamydia trachomatis infection can be eliminated in communities in Nepal following mass antibiotic distributions with azithromycin. The investigators will study both clinical trachoma and ocular C. trachomatis infection. The overall objective is to determine if the current World Health Organization (WHO) treatment strategy results in elimination of trachoma and infection.

1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensiti1. The investigators hypothesize that 24 communities in Kanchanpur, Kailali, and Achham districts of Nepal which receive mass antibiotic treatments will achieve elimination of trachoma as a public health problem (clinical disease \<5% in children 1-9 years old) more frequently than communities which have not received antibiotic treatments.

2. The investigators hypothesize that infection with C. trachomatis will be undetectable in all members within a community following mass treatment as determined by the most highly sensitive nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).ve nucleic acid amplification testing available (mRNA-based APTIMA and DNA-based AMPLICOR PCR).

Detailed Description

Here we evaluate whether ocular chlamydia infection and clinical trachoma are eliminated from 24 communities in western Nepal following a mass antibiotic distribution program. It is unknown if repeated treatments should continue or can be stopped thereby minimizing side effects and the high cost of medicine distribution. The investigators plan to randomize individuals to two groups to study the effects of a mass antibiotic distribution program: 1) treatment of antibiotics and 2) delayed treatment of antibiotics (after 4-6 months).

Study Timeline

• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Study Start: 2014-08
• Primary Completion: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children aged 1-9 years
• Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal

Exclusion Criteria

• All individuals who are allergic to macrolides
• All pregnant woman
• All neonates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic	Azithromycin	Azithromycin, suspension (liquid), 1 gram, one-time dose

Primary Outcome Measures

Name	Time	Method
Trachoma (clinical and C. trachomatis)	12 months

Secondary Outcome Measures

Name	Time	Method
Malaria	12 months
Anthropometry (height for weight)	12 months

Trial Locations

Locations (1)

Geta Eye Hospital; 🇳🇵 Geta, Kailali, Nepal