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

March 16, 2012
March 30, 2012
March 2012
June 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01563640 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Insecticidal School Uniforms for Dengue Prevention in Thailand
Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Dengue
  • Other: permethrin insecticide
    commercial impregnation of clothing before transmission season
  • Other: washing
    normal washing of school uniforms
  • Placebo Comparator: normal school uniforms
    Intervention: Other: washing
  • Experimental: insecticide-treated school uniforms
    Intervention: Other: permethrin insecticide
Wilder-Smith A, Byass P, Olanratmanee P, Maskhao P, Sringernyuang L, Logan JG, Lindsay SW, Banks S, Gubler D, Louis VR, Tozan Y, Kittayapong P. The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand. Trials. 2012 Nov 15;13:212. doi: 10.1186/1745-6215-13-212.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
2300
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • pupils in participating schools

Exclusion Criteria:

  • skin sensitivity, exema
Both
7 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01563640
282589-T
Yes
Peter Byass, Umeå University
Umeå University
European Union
Principal Investigator: Annelies Wilder-Smith, MD Umeå University
Umeå University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP