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Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)
This study has been terminated.
(Insecticidal treatment of school uniforms did not last through a dengue season)
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: August 31, 2015
Last verified: August 2015
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | March 16, 2012 | |||
| Last Updated Date | August 31, 2015 | |||
| Start Date ICMJE | March 2012 | |||
| Primary Completion Date | June 2013 (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 ] 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 ] | |||
| 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 Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE | Dengue | |||
| Intervention ICMJE |
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| Study Arms |
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| Publications * |
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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 | Terminated | |||
| Enrollment ICMJE | 1825 | |||
| Completion Date | December 2014 | |||
| Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| PRS Account | Umeå University | |||
| Verification Date | August 2015 | |||
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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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