Brief Title
Nepal Elimination of Trachoma Study
Official Title
Nepal Elimination of Trachoma Study
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 Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Trachoma (clinical and C. trachomatis)
Secondary Outcome
Anthropometry (height for weight)
Condition
Trachoma
Intervention
Azithromycin
Study Arms / Comparison Groups
Antibiotic
Description: Azithromycin, suspension (liquid), 1 gram, one-time dose
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
August 2014
Primary Completion Date
August 2014
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
Gender
All
Ages
1 Year - 9 Years
Accepts Healthy Volunteers
No
Contacts
Bruce D Gaynor, MD, ,
Location Countries
Nepal
Location Countries
Nepal
Administrative Informations
NCT ID
NCT02176057
Organization ID
NETS-13-10961
Secondary IDs
K23EY019881
Responsible Party
Sponsor
Study Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI)
Study Sponsor
Bruce D Gaynor, MD, Principal Investigator, UCSF F. I. Proctor Foundation (California, USA)
Verification Date
May 2015