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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02176057
Other study ID # NETS-13-10961
Secondary ID K23EY019881
Status Withdrawn
Phase Phase 2/Phase 3
First received June 24, 2014
Last updated May 19, 2015
Start date August 2014

Study information

Verified date May 2015
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority Nepal: Nepal Health Research Council
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 9 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin


Locations

Country Name City State
Nepal Geta Eye Hospital Geta Kailali

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Eye Institute (NEI)

Country where clinical trial is conducted

Nepal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trachoma (clinical and C. trachomatis) 12 months No
Secondary Anthropometry (height for weight) 12 months No
Secondary Malaria 12 months No
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