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

Sponsor:

Collaborator:

European Union

Information provided by (Responsible Party):

Peter Byass, Umeå University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dengue	Other: permethrin insecticide Other: washing	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1825 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand
Study Start Date :	March 2012
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Drug Information available for: Permethrin

Genetic and Rare Diseases Information Center resources: Dengue Fever Viral Hemorrhagic Fever

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: normal school uniforms washing only	Other: washing normal washing of school uniforms, without permethrin insecticide impregnation
Experimental: insecticide-treated school uniforms washing and insecticide treatment	Other: permethrin insecticide commercial permethrin insecticide impregnation of clothing before transmission season

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms [ Time Frame: up to 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years to 15 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

pupils in participating schools

Exclusion Criteria:

skin sensitivity, exema

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563640

Locations

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Thailand
Centre of Excellence for Vectors and Vector-Borne Diseases, Mahidol University
Salaya, Thailand

Sponsors and Collaborators

Umeå University

European Union

Investigators

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Principal Investigator:	Annelies Wilder-Smith, MD	Umeå University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Peter Byass, Professor of Global Health, Umeå University
ClinicalTrials.gov Identifier:	NCT01563640
Other Study ID Numbers:	282589-T
First Posted:	March 27, 2012 Key Record Dates
Last Update Posted:	September 1, 2015
Last Verified:	August 2015

Keywords provided by Peter Byass, Umeå University:


dengue

Additional relevant MeSH terms:

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Dengue Arbovirus Infections Virus Diseases Flavivirus Infections Flaviviridae Infections	RNA Virus Infections Hemorrhagic Fevers, Viral Permethrin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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