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Clinical Trials/NCT00938379
NCT00938379UnknownPhase 3

Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR

London School of Hygiene and Tropical Medicine1 site in 1 country5,000 target enrollmentStarted: July 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Enrollment
5,000
Locations
1
Primary Endpoint
reduction in malaria incidence

Study Overview

Brief Summary

Rural communities involved in agriculture are often at highest risk of insect-borne diseases in Southeast (SE) Asia.

Skin-applied insect repellents may prove a useful means of reducing mosquito-borne diseases for those people working outdoors in high risk areas.

This trial is evaluating the use of insect repellent (20% diethyltoluamide) to reduce incidence of malaria, Japanese Encephalitis and Dengue. The investigators will recruit up to 1000 households from 100 villages in rural Laos. In each house the investigators shall recruit up to 5 individuals. Half of households will be randomised to repellent, half to a placebo. All individuals will be provided with insecticide treated bed nets for use at night. All household occupants will be followed for 7 months to record malaria cases by Rapid Diagnostic Test every month. Blood spots will be collected at start and end of study to measure Japanese Encephalitis and Dengue. All positive cases will be promptly treated. Outcome will be reduction in number of malaria cases (primary outcome) and Dengue/Japanese Encephalitis (secondary outcomes).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 70 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • working in agriculture
  • available for monthly follow-up

Exclusion Criteria

  • allergy to repellent
  • pregnant / breastfeeding

Arms & Interventions

20% deet insect repellent

Experimental

experimental intervention

Intervention: 20% deet insect repellent (Drug)

lotion without repellent active

Placebo Comparator

Intervention: placebo control (Drug)

Outcomes

Primary Outcomes

reduction in malaria incidence

Time Frame: monthly over 7 months

Secondary Outcomes

  • Reduction in Japanese Encephalitis and / or Dengue infections(After 7 months intervention)

Investigators

Study Sites (1)

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