Nepal Elimination of Trachoma Study

NCT ID: NCT02176057

Last Updated: 2015-05-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31

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).

Conditions

Trachoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Antibiotic

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

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

Observation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Azithromycin

Intervention Type: DRUG

Other Intervention Names

Zithromax

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Eye Institute (NEI)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce D Gaynor, MD

Role: PRINCIPAL_INVESTIGATOR

UCSF F. I. Proctor Foundation (California, USA)

Locations

Geta Eye Hospital

Geta, Kailali, Nepal

Countries

Nepal

Other Identifiers

K23EY019881

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NETS-13-10961

Identifier Type: -

Identifier Source: org_study_id