Nepal Elimination of Trachoma Study

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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