Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)

Tracking Information
First Submitted Date ICMJE	March 16, 2012
First Posted Date ICMJE	March 27, 2012
Last Update Posted Date	September 1, 2015
Study Start Date ICMJE	March 2012
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 22, 2012)	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 ]; 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01563640 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 22, 2012)	comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Insecticidal School Uniforms for Dengue Prevention in Thailand
Official Title ICMJE	Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Dengue
Intervention ICMJE	Other: permethrin insecticide commercial permethrin insecticide impregnation of clothing before transmission season; Other: washing normal washing of school uniforms, without permethrin insecticide impregnation
Study Arms	Placebo Comparator: normal school uniforms washing only Intervention: Other: washing; Experimental: insecticide-treated school uniforms washing and insecticide treatment Intervention: Other: permethrin insecticide
Publications *	Kittayapong P, Olanratmanee P, Maskhao P, Byass P, Logan J, Tozan Y, Louis V, Gubler DJ, Wilder-Smith A. Mitigating Diseases Transmitted by Aedes Mosquitoes: A Cluster-Randomised Trial of Permethrin-Impregnated School Uniforms. PLoS Negl Trop Dis. 2017 Jan 19;11(1):e0005197. doi: 10.1371/journal.pntd.0005197. eCollection 2017 Jan.; 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.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: August 31, 2015)	1825
Original Estimated Enrollment ICMJE; (submitted: March 22, 2012)	2300
Actual Study Completion Date	December 2014
Actual Primary Completion Date	June 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: pupils in participating schools Exclusion Criteria: skin sensitivity, exema
Sex/Gender	Sexes Eligible for Study: All
Ages	7 Years to 15 Years (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Thailand
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01563640
Other Study ID Numbers ICMJE	282589-T
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Peter Byass, Umeå University
Study Sponsor ICMJE	Umeå University
Collaborators ICMJE	European Union
Investigators ICMJE	Principal Investigator: Annelies Wilder-Smith, MD Umeå University
PRS Account	Umeå University
Verification Date	August 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP