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

Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00938379
• Other study ID #: NHLAO1
• Status: Recruiting
• Phase: Phase 3
• First received: July 10, 2009
• Last updated: July 13, 2009
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2009
• Source: London School of Hygiene and Tropical Medicine
• Contact: Vanessa Chen-Hussey, MSc
• Email: vanessa.chen-hussey[@]lshtm.ac.uk
• Is FDA regulated: No
• Health authority: Laos: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 70 Years

Eligibility

Inclusion Criteria:

• working in agriculture

• available for monthly follow-up

Exclusion Criteria:

• allergy to repellent

• pregnant / breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dengue
• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis
• Malaria

Intervention

Drug:
• 20% deet insect repellent
skin-applied repellent lotion
• placebo control
Identical base formulation of lotion but without any deet active

Locations

Country	Name	City	State
Lao People's Democratic Republic	Rural villages in Attepu and Sekong Provinces, Laos PDR	Pakse	Attepu

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Population Services International

Country where clinical trial is conducted

Lao People's Democratic Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in malaria incidence		monthly over 7 months	No
Secondary	Reduction in Japanese Encephalitis and / or Dengue infections		After 7 months intervention	No