Nepal Elimination of Trachoma Study

Study Overview
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Brief Summary
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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. 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. 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
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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).

Official Title
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Nepal Elimination of Trachoma Study

Conditions
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Trachoma

Intervention / Treatment
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* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antibiotic<br>Azithromycin, suspension (liquid), 1 gram, one-time dose | Drug: Azithromycin<br> <br> * Other names: Zithromax;|
| No Intervention: Observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trachoma (clinical and C. trachomatis) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometry (height for weight) |  | 12 months | 
| Malaria |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trachoma