Partnership for Rapid Elimination of Trachoma - Full Text View

Sponsors and Collaborators:	Johns Hopkins University Bill and Melinda Gates Foundation
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00792922

Purpose

Trachoma, an ocular infection caused by C. trachomatis, is the second leading infectious cause of blindness worldwide. Years of repeated infection with C. trachomatis cause the eyelid to scar and contract and ultimately to rotate inward such that the eyelashes rub against the eyeball and abrade the cornea (trichiasis). The World Health Organization (WHO) has endorsed a multi-faceted strategy to combat trachoma, which includes the use of antibiotic treatment to reduce the community pool of infection with C. trachomatis. The objective of this study is to conduct a randomized, community-based trial in three countries (Ethiopia, Tanzania and The Gambia), representing different baseline endemicities, of alternative coverages and frequencies of administration of mass antibiotic treatment as well as to determine the cost-effectiveness of these different strategies from a program perspective.

Condition	Intervention	Phase
Trachoma	Drug: Azithromycin	Phase IV

MedlinePlus related topics: Antibiotics Eye Infections

Drug Information available for: Azithromycin BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study
Official Title:	Research to Programs for Trachoma Elimination: Antibiotic Trial

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Community prevalence of trachoma and ocular C. trachomatis infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Community costs of mass treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Community costs of incident infection [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	15000
Study Start Date:	May 2008
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
≥90% coverage target: Active Comparator Selected communities will receive mass treatment annually for three years.	Drug: Azithromycin Comparison of community coverage rate
80%-89% coverage target: Active Comparator Selected communities will receive mass treatment annually for three years.	Drug: Azithromycin Comparison of community coverage rate
≥90% coveage, treatment based: Active Comparator Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Ethiopia, treatment will be every 6-months for children ages twelve and under.	Drug: Azithromycin Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Ethiopia, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
80%-89% coverage: treatment based: Active Comparator Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5% In Ethiopia, treatment will be every 6-months for children ages twelve and under.	Drug: Azithromycin Comparison of coverage levels at baseline treatment followed by annual treatment if prevalence of trachoma is >5%. In Ethiopia, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.

Detailed Description:

A randomized, 2x2 factorial designed trial will be implemented in each of the three countries. Communities will be randomized to two different coverage targets (80%-89% versus ≥90%) for three years of mass treatment.

In The Gambia and Tanzania, communities will be further randomized to yearly mass treatment versus mass treatment at baseline followed by yearly mass treatment only if trachoma prevalence in sentinel children is greater than 5%. The communities will continue to be followed and treatment will resume if trachoma prevalence is found to be 20% or greater at the 12 or 18 month surveys.

In Ethiopia, communities will be randomized to the different coverage levels for annual mass azithromycin distribution and further randomized to biannual treatment at the two coverage targets for children ages twelve or younger.

Cross-sectional rates of trachoma and infection will be determined by examining sentinel children, age five years or younger, randomly selected from each community based on a community census. The census will be updated each year, and villages will be monitored at baseline, 6, 12, 18, 24, 30, and 36 months for infection and clinical disease.

The three-year study is in accord with the WHO guidelines which recommend three years of annual mass treatment followed by a re-survey to determine need for further treatment. We will evaluate the efficacy of guiding further mass treatment according to a laboratory test for Chlamydia or WHO guidelines. Where we estimate communities have infection rates less than 5% in sentinel children, or TF rates less than 5%, the community will be "graduated" from further mass treatment and followed for up to three years to look for evidence of re-emergent infection and disease. If rates of infection are found to be 20% or more return at the 12 or 18 month survey, mass treatment will be re-initiated.

Eligibility

Ages Eligible for Study:	up to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria for communities:

They are accessible by vehicle
The community leaders consent to have the community enrolled
Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community
The community size is <5,000 persons or >900 persons.

If a community meets the inclusion criteria and community leaders consent to have the community enrolled, then sentinel children will be selected based on the following criteria:

The child is age 5 years or younger
The child must be a resident in an eligible, sample community (defined as either living in the community since birth, or moved in with parents or guardians).
The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
The child must be willing to have a swab taken as part of being a sentinel child (this is critical for The Gambia and Tanzania, as each swab result counts towards meeting the stopping rule)
The child must have an identifiable guardian capable of providing consent to participate.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792922

Contacts

Contact: Sheila West, PhD	410-955-2606	shwest@jhmi.edu
Contact: Emily Gower, PhD	410-614-3874	egower1@jhmi.edu

Locations

United States, California
UCSF Proctor Foundation	Not yet recruiting
San Francisco, California, United States, 94143
Contact: Thomas Lietman, MD 415-502-2662 Tom.Lietman@ucsf.edu
Contact: Jenafir House, MPH, MSW 415.514.1616 jenafir.house@ucsf.edu
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Sheila West, PhD 410-955-2606 shwest@jhmi.edu
United Kingdom
London School of Hygiene and Tropical Medicine	Recruiting
London, United Kingdom, WC1E 7HT
Contact: Robin Bailey +44 207 927 29 14 robin.bailey@lshtm.ac.uk

Sponsors and Collaborators

Johns Hopkins University

Bill and Melinda Gates Foundation

Investigators

Principal Investigator:

Sheila West, PhD

Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins University School of Medicine ( Sheila West, PhD )
Study ID Numbers:	NA_00018439
Study First Received:	November 17, 2008
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00792922
Health Authority:	United States: Institutional Review Board; Tanzania: National Institute for Medical Research; Gambia: MRC Ethics Committee

Keywords provided by Johns Hopkins University:

Trachoma
Azithromycin
Mass treatment

Study placed in the following topic categories:

Bacterial Infections
Corneal Diseases
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Azithromycin
Eye Diseases

Chlamydia Infections
Eye Infections
Conjunctivitis
Conjunctival Diseases
Gram-Negative Bacterial Infections
Trachoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Chlamydiaceae Infections

Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009