- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938379
Clinical Evaluation of Insect Repellent and Insecticide Treated Nets in Lao PDR
Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Vanessa Chen-Hussey, MSc
- Email: vanessa.chen-hussey@lshtm.ac.uk
Study Locations
-
-
Attepu
-
Pakse, Attepu, Lao People's Democratic Republic
- Recruiting
- Rural villages in Attepu and Sekong Provinces, Laos PDR
-
Contact:
- Vanessa Chen-Hussey, MSc
- Phone Number: 116 856 (0)21 353 408
- Email: vanessa.chen-hussey@lshtm.ac.uk
-
Principal Investigator:
- Vanessa Chen-Hussey, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- working in agriculture
- available for monthly follow-up
Exclusion Criteria:
- allergy to repellent
- pregnant / breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 20% deet insect repellent
experimental intervention
|
skin-applied repellent lotion
|
Placebo Comparator: lotion without repellent active
|
Identical base formulation of lotion but without any deet active
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
reduction in malaria incidence
Time Frame: monthly over 7 months
|
monthly over 7 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in Japanese Encephalitis and / or Dengue infections
Time Frame: After 7 months intervention
|
After 7 months intervention
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Parasitic Diseases
- Protozoan Infections
- Hemorrhagic Fevers, Viral
- Encephalitis, Japanese
- Encephalitis
- Malaria
- Dengue
- Physiological Effects of Drugs
- Protective Agents
- Insect Repellents
Other Study ID Numbers
- NHLAO1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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