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Partnership for Rapid Elimination of Trachoma (PRET)
This study is currently recruiting participants.
Verified November 2011 by Johns Hopkins University

First Received on November 17, 2008.   Last Updated on November 7, 2011   History of Changes
Sponsor: Johns Hopkins University
Collaborator: Bill and Melinda Gates Foundation
Information provided by (Responsible Party): Sheila K West, 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 (Niger, 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research to Programs for Trachoma Elimination: Antibiotic Trial

Resource links provided by NLM:


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 ]
  • Macrolide resistance in pneumococcus (% resistance over time, clustered by randomization unit) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    PRET Niger

  • Anthropometric measurements (WHZ, WAZ, HAZ, MUACZ), as outlined by WHO child growth standards (0-5 years of age) [ Time Frame: 12-36 months after baseline ] [ Designated as safety issue: No ]
    PRET Niger

  • Prevalence of anemia (hemoglobin levels in 0-5 year olds) and the prevalence of malaria [ Time Frame: 12 - 36 months after baseline ] [ Designated as safety issue: No ]
    PRET Niger

  • Mortality in 1-5 year old study children [ Time Frame: Over study period ] [ Designated as safety issue: No ]
    PRET Gambia

  • Cause-specific mortality in 1-5 year olds assessed by verbal autopsy [ Time Frame: Over study period ] [ Designated as safety issue: No ]
    PRET Gambia

  • Mortality in adults in the study area [ Time Frame: Over study period ] [ Designated as safety issue: No ]
    PRET Gambia

  • Cause-specific mortality in adults assessed by verbal autopsy [ Time Frame: Over study period ] [ Designated as safety issue: No ]
    PRET Gambia

  • Morbidity among 1-5 year old study children as assessed by height for age, weight for age, weight for height, body mass index and Hackett spleen size [ Time Frame: 30 months after baseline ] [ Designated as safety issue: No ]
    PRET Gambia

  • Serotype distribution, antibiotic sensitivity profile and MLST type of Streptococcus pneumoniae carried in the nasopharynx of study children [ Time Frame: 30 months after baseline ] [ Designated as safety issue: No ]
    PRET Gambia


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
Active Comparator: ≥90% coverage target
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Comparison of community coverage rate
Other Name: Zithromax
Active Comparator: 80%-89% coverage target
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Comparison of community coverage rate
Other Name: Zithromax
Active Comparator: ≥90% coveage, treatment based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, 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 Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Name: Zithromax
Active Comparator: 80%-89% coverage: treatment based

Treatment to be administered at baseline then continued yearly if trachoma prevalence is greater than 5%

In Niger, 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 Niger, there will be a comparison of coverage levels in everyone versus in children ages twelve and under who are treated every 6-months.
Other Name: Zithromax

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 Niger, 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:

  1. Communities are located in the target districts and accessible by vehicle
  2. The community leaders consent to have the community enrolled
  3. Rapid assessment and/or available data suggest trachoma rates are higher than 20% in the community.
  4. The community size is <5,000 persons or >250 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:

  1. The child is age 5 years or younger
  2. 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).
  3. The child must not have an ocular condition that would preclude grading trachoma or taking an ocular specimen.
  4. 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)
  5. 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: Jennifer Lee, MSPH 410-502-9810 jlee366@jhmi.edu

Locations
United States, California
UCSF Proctor Foundation Recruiting
San Francisco, California, United States, 94143
Contact: Thomas Lietman, MD     415-502-2662     Tom.Lietman@ucsf.edu    
Contact: Nicole Stoller, MPH     415.476.2460     nicole.stoller@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

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sheila K West, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00792922     History of Changes
Other Study ID Numbers: NA_00018439
Study First Received: November 17, 2008
Last Updated: November 7, 2011
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

Additional relevant MeSH terms:
Trachoma
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Eye Infections
Infection
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012