A Cluster Randomized Trial to Evaluate Long Lasting Insec... | NCT00853281

Studies
A Cluster Randomized Trial to Evaluate Long Lasting Insecticidal Hammocks to Prevent Forest Malaria in Vietnam

NCT00853281

Sponsor

Institute of Tropical Medicine, Belgium

Status

Completed

Last Update Posted

Sep 14, 2010Estimated

Enrollment

18,646Actual

Phase

Not Applicable

Conditions

Malaria

Interventions

Hammocks with LLIN
Standard vector control measures

Countries

Vietnam

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Dec 2006Actual

Completion Date

Jun 2007Actual

First Submitted Date

Feb 27, 2009

First Submission Date that Met QC Criteria

Feb 27, 2009

First Posted Date

Mar 2, 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

Sep 12, 2010

Last Update Posted Date

Sep 14, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Institute of Tropical Medicine, BelgiumOTHER

Collaborators

Name	Class
National Institute of Malariology, Parasitology and Entomology, Vietnam	OTHER_GOV
London School of Hygiene and Tropical Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffer a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.

The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets).

Detailed Description

In Central Vietnam, forest malaria remains difficult to control due to the complex interactions between human, vector and environmental factors. A community-based study carried out between 1999 and 2001 showed that regular forest activity was a strong risk factor for malaria infection. Untreated bednets had a significantly protecting effect for villagers, except for those regularly sleeping in the forest, who suffered a significantly higher number of clinical attacks. Thus, there is need to target this high-risk group with new intervention based on long-lasting insecticidal materials. Hammocks are extensively used by people working in the forest, therefore long-lasting insecticidal hammocks (LLIH) could achieve a good individual protection.

The Investigators proposed to evaluate their effectiveness in a community-based trial, comparing them to the standard vector control methods (insecticide-treated nets): communities have been grouped into clusters of about 1000 înhabitants, and clusters were randomized to either the active intervention or the active control, and followed up for 24 month.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18,646Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hammocks with LLIN	Experimental	Locally-made hammocks covered with long-lasting insecticidal net (LLIN)- Olyset(R), used in addition to the standard vector control measures	Other: Hammocks with LLIN
ITN	Active Comparator	Standard vector control measures (insectice-treated net or ITN)	Other: Standard vector control measures

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hammocks with LLIN	Other	Locally-made hammocks covered with long lasting insecticidal nel (LLIN)	Hammocks with LLIN

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of malaria prevalence and incidence		24 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction of malaria sero-prevalence		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All residents in the 20 concerned study clusters and willing to give informed consent to participate

Exclusion Criteria:

People not willing to give informed consent to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Annette Erhart, MD	Institute of Tropical Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ninh Thuan Provincial Malaria Station		Phan Rang-Tháp Chàm	Ninh Thuan		Vietnam

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19809502	Derived	Thang ND, Erhart A, Speybroeck N, Xa NX, Thanh NN, Ky PV, Hung le X, Thuan le K, Coosemans M, D'Alessandro U. Long-Lasting Insecticidal Hammocks for controlling forest malaria: a community-based trial in a rural area of central Vietnam. PLoS One. 2009 Oct 7;4(10):e7369. doi: 10.1371/journal.pone.0007369.

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