Partnership for Rapid Elimination of Trachoma (PRET)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Sheila K West, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00792922
First received: November 17, 2008
Last updated: April 3, 2013
Last verified: April 2013
  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 4

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

  • Rates of health clinic visits overall, for infectious diseases, diarrhea, malaria, respiratory disease, and antibiotics distributed [ Time Frame: 12, 24, and 36 months after baseline ] [ Designated as safety issue: No ]
    PRET Niger

  • Mortality in children [ Time Frame: Over study period ] [ Designated as safety issue: No ]
    PRET Niger

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


Estimated Enrollment: 15000
Study Start Date: May 2008
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
UCSF Proctor Foundation
San Francisco, California, United States, 94143
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, WC1E 7HT
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: April 3, 2013
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

ClinicalTrials.gov processed this record on September 30, 2014