Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
European Union
Information provided by (Responsible Party):
Peter Byass, Umeå University
ClinicalTrials.gov Identifier:
NCT01563640
First received: March 16, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

This is a randomised controlled trial that will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-15 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent high quality of insecticide impregnation with permethrin. A double-blind randomised cross-over trial at the school level will cover two dengue transmission seasons.


Condition Intervention
Dengue
Other: permethrin insecticide
Other: washing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • insecticide:placebo incidence rate-ratio (per 1,000 person-years) of laboratory-confirmed dengue cases in school-aged children [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Schools are cross-over randomised to insecticide-treated or untreated (placebo) school uniforms, and so the primary outcome is the rate-ratio of dengue fever cases in school children, compared between these two groups.


Secondary Outcome Measures:
  • comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2300
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: normal school uniforms Other: washing
normal washing of school uniforms
Experimental: insecticide-treated school uniforms Other: permethrin insecticide
commercial impregnation of clothing before transmission season

  Eligibility

Ages Eligible for Study:   7 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pupils in participating schools

Exclusion Criteria:

  • skin sensitivity, exema
  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: NCT01563640

Locations
Thailand
Centre of Excellence for Vectors and Vector-Borne Diseases, Mahidol University
Salaya, Thailand
Sponsors and Collaborators
Umeå University
European Union
Investigators
Principal Investigator: Annelies Wilder-Smith, MD Umeå University
  More Information

Additional Information:
No publications provided by Umeå University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Byass, Professor of Global Health, Umeå University
ClinicalTrials.gov Identifier: NCT01563640     History of Changes
Other Study ID Numbers: 282589-T
Study First Received: March 16, 2012
Last Updated: March 30, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Umeå University:
dengue

Additional relevant MeSH terms:
Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014