Nepal Elimination of Trachoma Study

Trachoma Clinical Trial

— NETS  

Official title:

Nepal Elimination of Trachoma Study

Clinical Trial Details — Status: Withdrawn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• Status: Withdrawn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. 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

• Trachoma

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