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Insecticidal School Uniforms for Dengue Prevention in Thailand (DengueTools)

Primary Purpose

Dengue

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
permethrin insecticide
washing
Sponsored by
Umeå University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue focused on measuring dengue

Eligibility Criteria

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • pupils in participating schools

Exclusion Criteria:

  • skin sensitivity, exema

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

normal school uniforms

insecticide-treated school uniforms

Arm Description

washing only

washing and insecticide treatment

Outcomes

Primary Outcome Measures

insecticide:placebo incidence rate-ratio (per 1,000 person-years) of laboratory-confirmed dengue cases in school-aged children
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

Full Information

First Posted
March 16, 2012
Last Updated
August 31, 2015
Sponsor
Umeå University
Collaborators
European Union
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1. Study Identification

Unique Protocol Identification Number
NCT01563640
Brief Title
Insecticidal School Uniforms for Dengue Prevention in Thailand
Acronym
DengueTools
Official Title
Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Insecticidal treatment of school uniforms did not last through a dengue season
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
Collaborators
European Union

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue
Keywords
dengue

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1825 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal school uniforms
Arm Type
Placebo Comparator
Arm Description
washing only
Arm Title
insecticide-treated school uniforms
Arm Type
Experimental
Arm Description
washing and insecticide treatment
Intervention Type
Other
Intervention Name(s)
permethrin insecticide
Intervention Description
commercial permethrin insecticide impregnation of clothing before transmission season
Intervention Type
Other
Intervention Name(s)
washing
Intervention Description
normal washing of school uniforms, without permethrin insecticide impregnation
Primary Outcome Measure Information:
Title
insecticide:placebo incidence rate-ratio (per 1,000 person-years) of laboratory-confirmed dengue cases in school-aged children
Description
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.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: pupils in participating schools Exclusion Criteria: skin sensitivity, exema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annelies Wilder-Smith, MD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Excellence for Vectors and Vector-Borne Diseases, Mahidol University
City
Salaya
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
28103255
Citation
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.
Results Reference
derived
PubMed Identifier
23153360
Citation
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.
Results Reference
derived
Links:
URL
http://www.denguetools.net
Description
Related Info

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Insecticidal School Uniforms for Dengue Prevention in Thailand

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