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Trial record 1 of 1 for:    NCT00792922
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Partnership for Rapid Elimination of Trachoma (PRET)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792922
First Posted: November 18, 2008
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Johns Hopkins University
  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
Intervention Model: Factorial Assignment
Intervention Model Description:

The study was a factorial study model to begin with in all 3 countries (Niger,Tanzania and Gambia) but because we never stopped treatment in Tanzania and Niger site.Hence the study design was collapsed to a simple design in Tanzania and Niger.The study model was kept as a factorial design for the Gambia site.

Protocol Enrollment refers to the number of communities, not the number of participants enrolled.

Masking: Single (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 (CT) Infection at Baseline [ Time Frame: At baseline ]

    Mass drug administration (MDA) with azithromycin or topical tetracycline is recommended by World Health Organization (WHO) for 3 years in districts where the prevalence of trachoma is>=10 % in children aged 1-9 years.

    The prevalence of trachoma (TF) was measured using the Simplified WHO Grading System. Both eyelids were everted and tarsal conjunctiva graded for signs of clinical trachoma. Ocular photographs of right eye were taken on random samples of sentinel children to determine the drift in grading over time. To detect CT infection, an ocular swab of the right eye using a Dacron swab was collected from the sentinel kids. The swab was stored dry, and frozen until shipped and processed in the laboratory. Air control swabs were also taken to test for field and laboratory contamination.


  • Community Prevalence of Trachoma and Ocular C. Trachomatis (CT) Infection at 36 Months [ Time Frame: 3 years ]

    100 random sentinel children aged 0- 5 years per community were to be examined for prevalence of trachoma & CT infection in Tanzania & Gambia.

    50-100 random sentinel children aged 0-5 years per community were to be examined in Niger per community for prevalence of TF and CT infection.

    Outcomes are reported at the community level because raw data could not be accessed.

    There is no way to determine how many participants were examined in each arm.



Enrollment: 128
Study Start Date: May 2008
Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ≥90% coverage with azithromycin 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 with azithromycin target
Selected communities will receive mass treatment annually for three years.
Drug: Azithromycin
Comparison of community coverage rate
Other Name: Zithromax
Active Comparator: ≥90% coverage with azithromycin , 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 with azithromycin : 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. The investigators will evaluate the efficacy of guiding further mass treatment according to a laboratory test for Chlamydia or WHO guidelines. Where investigators estimate communities have infection rates less than 5% in sentinel children, or trachomatous inflammation (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for communities:

  • Communities are located in the target districts and 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 >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:

  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00792922     History of Changes
Other Study ID Numbers: NA_00018439
First Submitted: November 17, 2008
First Posted: November 18, 2008
Results First Submitted: April 13, 2017
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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