Clinical trial NCT02176057: Nepal Elimination of Trachoma Study
Official title: Nepal Elimination of Trachoma Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Trachoma
Keywords: trachoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2014-06-26
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Trachoma (clinical and C. trachomatis)
timeFrame: 12 months
Secondary outcomes:
measure: Anthropometry (height for weight)
timeFrame: 12 months
measure: Malaria
timeFrame: 12 months
Other outcomes:
Locations:
city: Geta
country: Nepal
facility: Geta Eye Hospital
state: Kailali
Study officials:
affiliation: UCSF F. I. Proctor Foundation (California, USA)
name: Bruce D Gaynor, MD
role: PRINCIPAL_INVESTIGATOR
References: