Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR

Phase 3

• Conditions: Malaria; Dengue; Japanese Encephalitis
• Interventions: Drug: 20% deet insect repellent; Drug: placebo control

• Registration Number: NCT00938379
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study Start: 2009-07
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Last Update Submitted: 2009-07-13
• Last Update Posted: 2009-07-14
• Primary Completion: 2010-12
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• working in agriculture
• available for monthly follow-up

Exclusion Criteria

• allergy to repellent
• pregnant / breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
20% deet insect repellent	20% deet insect repellent	experimental intervention
lotion without repellent active	placebo control	-

Primary Outcome Measures

Name	Time	Method
reduction in malaria incidence	monthly over 7 months

Secondary Outcome Measures

Name	Time	Method
Reduction in Japanese Encephalitis and / or Dengue infections	After 7 months intervention

Trial Locations

Locations (1)

Rural villages in Attepu and Sekong Provinces, Laos PDR; 🇱🇦 Pakse, Attepu, Lao People's Democratic Republic