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
  Purpose

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).


Condition Intervention Phase
Malaria
Dengue
Japanese Encephalitis
Drug: 20% deet insect repellent
Drug: placebo control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Insect Repellent and Insecticide Treated Nets Against Malaria, JE & Dengue in Rural Communities in Lao PDR

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • reduction in malaria incidence [ Time Frame: monthly over 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in Japanese Encephalitis and / or Dengue infections [ Time Frame: After 7 months intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: July 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20% deet insect repellent
experimental intervention
Drug: 20% deet insect repellent
skin-applied repellent lotion
Placebo Comparator: lotion without repellent active Drug: placebo control
Identical base formulation of lotion but without any deet active

  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • working in agriculture
  • available for monthly follow-up

Exclusion Criteria:

  • allergy to repellent
  • pregnant / breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938379

Contacts
Contact: Vanessa Chen-Hussey, MSc vanessa.chen-hussey@lshtm.ac.uk

Locations
Lao People's Democratic Republic
Rural villages in Attepu and Sekong Provinces, Laos PDR Recruiting
Pakse, Attepu, Lao People's Democratic Republic
Contact: Vanessa Chen-Hussey, MSc    856 (0)21 353 408 ext 116    vanessa.chen-hussey@lshtm.ac.uk   
Principal Investigator: Vanessa Chen-Hussey, MSc         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Population Services International
Investigators
Principal Investigator: Nigel Hill, PhD LSHTM
  More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Nigel Hill, Head of Unit, Disease Control & Vector Biology
ClinicalTrials.gov Identifier: NCT00938379     History of Changes
Other Study ID Numbers: NHLAO1
Study First Received: July 10, 2009
Last Updated: July 13, 2009
Health Authority: Laos: Ethics Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
mosquito
repellent
vector control
malaria

Additional relevant MeSH terms:
Dengue
Encephalitis
Encephalitis, Japanese
Malaria
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Central Nervous System Viral Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Encephalitis, Arbovirus
Encephalitis, Viral
Protozoan Infections
Parasitic Diseases
DEET
Insect Repellents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014