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Nepal Elimination of Trachoma Study (NETS)

Primary Purpose

Trachoma

Status
Withdrawn
Phase
Phase 2
Locations
Nepal
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trachoma focused on measuring trachoma

Eligibility Criteria

1 Year - 9 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Geta Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antibiotic

Observation

Arm Description

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

Outcomes

Primary Outcome Measures

Trachoma (clinical and C. trachomatis)

Secondary Outcome Measures

Anthropometry (height for weight)
Malaria

Full Information

First Posted
June 24, 2014
Last Updated
May 19, 2015
Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT02176057
Brief Title
Nepal Elimination of Trachoma Study
Acronym
NETS
Official Title
Nepal Elimination of Trachoma Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Nepal Ministry of Health implemented public drug treatment prior to the proposed start date
Study Start Date
August 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Eye Institute (NEI)

4. Oversight

5. Study Description

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. 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trachoma
Keywords
trachoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic
Arm Type
Experimental
Arm Description
Azithromycin, suspension (liquid), 1 gram, one-time dose
Arm Title
Observation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
Zithromax
Primary Outcome Measure Information:
Title
Trachoma (clinical and C. trachomatis)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anthropometry (height for weight)
Time Frame
12 months
Title
Malaria
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce D Gaynor, MD
Organizational Affiliation
UCSF F. I. Proctor Foundation (California, USA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geta Eye Hospital
City
Geta
State/Province
Kailali
ZIP/Postal Code
10900
Country
Nepal

12. IPD Sharing Statement

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Nepal Elimination of Trachoma Study

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