Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)
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ClinicalTrials.gov Identifier: NCT01563640 |
Recruitment Status
:
Terminated
(Insecticidal treatment of school uniforms did not last through a dengue season)
First Posted
: March 27, 2012
Last Update Posted
: September 1, 2015
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Sponsor:
Umeå University
Collaborator:
European Union
Information provided by (Responsible Party):
Peter Byass, Umeå University
Tracking Information | ||||
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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 |
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 Applicable | |||
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 | |||
Actual Enrollment ICMJE |
1825 | |||
Original Estimated Enrollment ICMJE |
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:
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 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |