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

NCT ID: NCT00938379

Last Updated: 2009-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Malaria Dengue Japanese Encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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20% deet insect repellent

experimental intervention

Group Type EXPERIMENTAL

20% deet insect repellent

Intervention Type DRUG

skin-applied repellent lotion

lotion without repellent active

Group Type PLACEBO_COMPARATOR

placebo control

Intervention Type DRUG

Identical base formulation of lotion but without any deet active

Interventions

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20% deet insect repellent

skin-applied repellent lotion

Intervention Type DRUG

placebo control

Identical base formulation of lotion but without any deet active

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* working in agriculture
* available for monthly follow-up

Exclusion Criteria

* allergy to repellent
* pregnant / breastfeeding
Minimum Eligible Age

5 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Population Services International

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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Head of Unit, Disease Control & Vector Biology

Principal Investigators

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Nigel Hill, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Rural villages in Attepu and Sekong Provinces, Laos PDR

Pakse, Attepu, Laos

Site Status RECRUITING

Countries

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Laos

Central Contacts

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Vanessa Chen-Hussey, MSc

Role: CONTACT

Facility Contacts

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Vanessa Chen-Hussey, MSc

Role: primary

856 (0)21 353 408 ext. 116

References

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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.

Reference Type DERIVED
PMID: 23967083 (View on PubMed)

Other Identifiers

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NHLAO1

Identifier Type: -

Identifier Source: org_study_id

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