Clinical Evaluation of Insect Repellent and Insecticide T... | NCT00938379

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

NCT00938379

Sponsor

London School of Hygiene and Tropical Medicine

Status

Unknown status

Last Update Posted

Jul 14, 2009Estimated

Enrollment

5,000Estimated

Phase

Phase 3

Conditions

Malaria
Dengue
Japanese Encephalitis

Interventions

20% deet insect repellent
placebo control

Countries

Laos

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Jun 2011Estimated

First Submitted Date

Jul 10, 2009

First Submission Date that Met QC Criteria

Jul 10, 2009

First Posted Date

Jul 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2009

Last Update Posted Date

Jul 14, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

London School of Hygiene and Tropical MedicineOTHER

Collaborators

Name	Class
Population Services International	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
20% deet insect repellent	Experimental	experimental intervention	Drug: 20% deet insect repellent
lotion without repellent active	Placebo Comparator		Drug: placebo control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
20% deet insect repellent	Drug	skin-applied repellent lotion	20% deet insect repellent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction in malaria incidence		monthly over 7 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in Japanese Encephalitis and / or Dengue infections		After 7 months intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

working in agriculture
available for monthly follow-up

Exclusion Criteria:

allergy to repellent
pregnant / breastfeeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanessa Chen-Hussey, MSc	Contact			vanessa.chen-hussey@lshtm.ac.uk

Overall Officials

Name	Affiliation	Role
Nigel Hill, PhD	London School of Hygiene and Tropical Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rural villages in Attepu and Sekong Provinces, Laos PDR	Recruiting	Pakse	Attepu		Laos

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23967083	Derived	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.

ID	Term
D008288	Malaria
D003715	Dengue
D004672	Encephalitis, Japanese

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases