Insecticidal School Uniforms for Dengue Prevention in Thailand

Dengue Clinical Trial

— DengueTools  

Official title:

Can Insecticide-treated School Uniforms Reduce Dengue Infections in School-aged Children in Thailand

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01563640
• Other study ID #: 282589-T
• Status: Terminated
• Phase: N/A
• First received: March 16, 2012
• Last updated: August 31, 2015
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1825
• Est. completion date: December 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

Inclusion Criteria:

• pupils in participating schools

Exclusion Criteria:

• skin sensitivity, exema

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dengue

Intervention

Other:
• permethrin insecticide
commercial permethrin insecticide impregnation of clothing before transmission season
• washing
normal washing of school uniforms, without permethrin insecticide impregnation

Locations

Country	Name	City	State
Thailand	Centre of Excellence for Vectors and Vector-Borne Diseases, Mahidol University	Salaya

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	European Union

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	comparison between intervention and placebo groups of number of serious skin reactions to insecticide-treated uniforms		up to 2 years	Yes

External Links

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