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

Primary Purpose

Malaria, Dengue, Japanese Encephalitis

Status

Unknown status

Phase

Phase 3

Locations

Lao People's Democratic Republic

Study Type

Interventional

Intervention

20% deet insect repellent

placebo control

About this trial

This is an interventional prevention trial for Malaria focused on measuring mosquito, repellent, vector control, malaria

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

working in agriculture
available for monthly follow-up

Exclusion Criteria:

allergy to repellent
pregnant / breastfeeding

Sites / Locations

Rural villages in Attepu and Sekong Provinces, Laos PDRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

20% deet insect repellent

lotion without repellent active

Arm Description

experimental intervention

Outcomes

Primary Outcome Measures

reduction in malaria incidence

Secondary Outcome Measures

Reduction in Japanese Encephalitis and / or Dengue infections

Full Information

NCT ID

NCT00938379

First Posted

July 10, 2009

Last Updated

July 13, 2009

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Population Services International

1. Study Identification

Unique Protocol Identification Number

NCT00938379

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2009

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

June 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Population Services International

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria, Dengue, Japanese Encephalitis

Keywords

mosquito, repellent, vector control, malaria

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

20% deet insect repellent

Arm Type

Experimental

Arm Description

experimental intervention

Arm Title

lotion without repellent active

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

20% deet insect repellent

Intervention Description

skin-applied repellent lotion

Intervention Type

Drug

Intervention Name(s)

placebo control

Intervention Description

Identical base formulation of lotion but without any deet active

Primary Outcome Measure Information:

Title

reduction in malaria incidence

Time Frame

monthly over 7 months

Secondary Outcome Measure Information:

Title

Reduction in Japanese Encephalitis and / or Dengue infections

Time Frame

After 7 months intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: working in agriculture available for monthly follow-up Exclusion Criteria: allergy to repellent pregnant / breastfeeding

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vanessa Chen-Hussey, MSc

vanessa.chen-hussey@lshtm.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nigel Hill, PhD

Organizational Affiliation

LSHTM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rural villages in Attepu and Sekong Provinces, Laos PDR

City

Pakse

State/Province

Attepu

Country

Lao People's Democratic Republic

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vanessa Chen-Hussey, MSc

Phone

856 (0)21 353 408

Ext

116

vanessa.chen-hussey@lshtm.ac.uk

First Name & Middle Initial & Last Name & Degree

Vanessa Chen-Hussey, MSc

12. IPD Sharing Statement

Citations:

PubMed Identifier

23967083

Citation

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.

Results Reference

derived

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

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