Nepal Elimination of Trachoma Study

NCT02176057 | Withdrawn Phase 2

• 2 other identifiers: NETS-13-10961K23EY019881
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Trachoma

Keywords

trachoma

Outcome Measures

Primary Outcomes (1)

• Trachoma (clinical and C. trachomatis)

  12 months

Secondary Outcomes (2)

• Anthropometry (height for weight)

  12 months

• Malaria

  12 months

Study Arms (2)

Antibiotic

EXPERIMENTAL

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

Drug: Azithromycin

Observation

NO INTERVENTION

Interventions

Azithromycin DRUG

Also known as: Zithromax

Antibiotic

Eligibility Criteria

• Age: 1 Year - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1-9 years
• Children who live in Kailai, Kanchanpur, or Achham Districts of Nepal

You may not qualify if:

• All individuals who are allergic to macrolides
• All pregnant woman
• All neonates

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

Geta Eye Hospital

Geṭā, Kailali, 10900, Nepal

Location

MeSH Terms

Conditions

Trachoma

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Conjunctivitis, Bacterial; Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Chlamydia Infections; Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Bruce D Gaynor, MD

  UCSF F. I. Proctor Foundation (California, USA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2014
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

NE (1)