Nepal Elimination of Trachoma Study (NETS)

University of California San Francisco (UCSF)

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Trachoma

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02176057

K23EY019881 (U.S. NIH Grant/Contract)

NETS-13-10961

Details and patient eligibility

About

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.

3. 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).

Full 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).

Sex: All

Ages: 1 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Antibiotic

Experimental group

Description:

Azithromycin, suspension (liquid), 1 gram, one-time dose

Treatment:

Drug: Azithromycin

Observation

No Intervention group