Nepal Elimination of Trachoma Study

checkorphan
Learn more about:
Trachoma
Related Clinical Trial
Safety of Co-administration of IDA and Azithromycin for NTDs ( ComboNTDs ) Azithromycin Reduction to Reach Elimination of Trachoma Safety Study of Combined Azithromycin, Ivermectin and Albendazole for Trachoma and Lymphatic Filariasis Modified Instrumentation for Surgery to Correct Trichiasis Smartphone App for Taking Images of Conjunctivae Water Uptake for Health in Amhara Pilot A Trial of Non-absorbable Versus Absorbable Sutures for Trichiasis Surgery Cluster RCT of Co-administration Azithromycin, Albendazole & Ivermectin Safety and Immunogenicity of a Chlamydia Vaccine CTH522 Fluorometholone as Ancillary Therapy for TT Surgery Performance of a Photoscreener for Vision Screening in a Haitian Pediatric Population Impact of Water and Health Education Programs on Trachoma and Ocular C. Trachomatis in Niger Trachoma Elimination Follow-up Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger Azithromycin in Control of Trachoma II Sanitation, Water, and Instruction in Face-washing for Trachoma I/II Efficacy and Safety of 2 Dosing Regimens of T1225 Eye Drops 1.5% Versus Oral Azithromycin in Treatment of Trachoma App-based Versus Slide-based Inter-grader Agreement (IGA) Test for Trachoma Graders Trachoma Elimination Study by Focused Antibiotic (TESFA) Kebele Elimination of Trachoma for Ocular Health A Surveillance and Azithromycin Treatment for Newcomers and Travelers Evaluation: The ASANTE Trial Testing Insect Repellents Against Musca Sorbens, the Vector of Trachoma Trachoma Amelioration in Northern Amhara (TANA) Tripartite International Research for the Elimination of Trachoma Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania Partnership for Rapid Elimination of Trachoma Nepal Elimination of Trachoma Study Study of Three Alternatives for Mass Treatment in Trachoma Villages of Tanzania

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