Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)
This study is enrolling participants by invitation only.
Sponsor:
Umeå University
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
| Tracking Information | |||||
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| First Received Date ICMJE | March 16, 2012 | ||||
| Last Updated Date | March 30, 2012 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| 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 |
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 ] | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Dengue | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 2300 | ||||
| Estimated Completion Date | December 2014 | ||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 15 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01563640 | ||||
| Other Study ID Numbers ICMJE | 282589-T | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Peter Byass, Umeå University | ||||
| Study Sponsor ICMJE | Umeå University | ||||
| Collaborators ICMJE | European Union | ||||
| Investigators ICMJE |
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| Information Provided By | Umeå University | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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