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Nepal Elimination of Trachoma Study

Nepal Elimination of Trachoma Study

Status
Withdrawn
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176057
Acronym
NETS
Enrollment
0
Registered
2014-06-26
Start date
2014-08-31
Completion date
Unknown
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trachoma

Keywords

trachoma

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).

Interventions

DRUGAzithromycin

Sponsors

National Eye Institute (NEI)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
1 Years to 9 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Trachoma (clinical and C. trachomatis)12 months

Secondary

MeasureTime frame
Anthropometry (height for weight)12 months
Malaria12 months

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026