Insecticidal School Uniforms for Dengue Prevention in Thailand

NCT01563640 | Terminated DMC

• 1 other identifier: 282589-T
• Study Type: interventional
• Target: 1,825
• Locations: 1 country
• Sites: 1

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.

Conditions

Dengue

Keywords

dengue

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 years

Secondary Outcomes (1)

• comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms

  up to 2 years

Study Arms (2)

normal school uniforms

PLACEBO COMPARATOR

washing only

Other: washing

insecticide-treated school uniforms

EXPERIMENTAL

washing and insecticide treatment

Other: permethrin insecticide

Interventions

permethrin insecticide OTHER

commercial permethrin insecticide impregnation of clothing before transmission season

insecticide-treated school uniforms

washing OTHER

normal washing of school uniforms, without permethrin insecticide impregnation

normal school uniforms

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• pupils in participating schools

You may not qualify if:

• skin sensitivity, exema

Sponsors & Collaborators

• Umeå University: lead
• European Union: collaborator

Study Sites (1)

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

Salaya, Thailand

Location

Related Publications (2)

• 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.

  PMID: 28103255 DERIVED

• 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.

  PMID: 23153360 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Dengue

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Annelies Wilder-Smith, MD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Global Health

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 27, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2014
• Last Updated: September 1, 2015

Record last verified: 2015-08

Locations

TH (1)