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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by London School of Hygiene and Tropical Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Population Services International
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT00938379
First received: July 10, 2009
Last updated: July 13, 2009
Last verified: July 2009

July 10, 2009
July 13, 2009
July 2009
December 2010   (final data collection date for primary outcome measure)
reduction in malaria incidence [ Time Frame: monthly over 7 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00938379 on ClinicalTrials.gov Archive Site
Reduction in Japanese Encephalitis and / or Dengue infections [ Time Frame: After 7 months intervention ] [ Designated as safety issue: No ]
Reduction in Japanese Encephylitis and / or Dengue infections [ Time Frame: After 7 months intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Malaria
  • Dengue
  • Japanese Encephalitis
  • Drug: 20% deet insect repellent
    skin-applied repellent lotion
  • Drug: placebo control
    Identical base formulation of lotion but without any deet active
  • Experimental: 20% deet insect repellent
    experimental intervention
    Intervention: Drug: 20% deet insect repellent
  • Placebo Comparator: lotion without repellent active
    Intervention: Drug: placebo control
Chen-Hussey V, Carneiro I, Keomanila H, Gray R, Bannavong S, Phanalasy S, Lindsay SW. Can topical insect repellents reduce malaria? A cluster-randomised controlled trial of the insect repellent N,N-diethyl-m-toluamide (DEET) in Lao PDR. PLoS One. 2013 Aug 14;8(8):e70664. doi: 10.1371/journal.pone.0070664. eCollection 2013.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
June 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • working in agriculture
  • available for monthly follow-up

Exclusion Criteria:

  • allergy to repellent
  • pregnant / breastfeeding
Both
5 Years to 70 Years
Yes
Contact: Vanessa Chen-Hussey, MSc vanessa.chen-hussey@lshtm.ac.uk
Lao People's Democratic Republic
 
NCT00938379
NHLAO1
Yes
Dr Nigel Hill, Head of Unit, Disease Control & Vector Biology
London School of Hygiene and Tropical Medicine
Population Services International
Principal Investigator: Nigel Hill, PhD LSHTM
London School of Hygiene and Tropical Medicine
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP