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Repellents as Added Control Measure to Long Lasting Insecticidal Nets (MalaResT)

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Mosquito topical repellent
Sponsored by
Institute of Tropical Medicine, Belgium
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Outdoor Malaria Transmission, Anopheles, Topical repellent, Early biting vector, Long Lasting Insecticidal Net (LLIN), Cambodia

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • All household members volunteering from selected communities

Exclusion Criteria:

  • Infants less than 2 years

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Topical Repellent & LLIN

Long Lasting Insecticidal Nets

Arm Description

Brand Name LLIN: Olyset Net Active ingredient: permethrin

Outcomes

Primary Outcome Measures

Change from baseline in malaria prevalence at 6 months
Malaria prevalence (PCR detection) will be measured in both study arms at the start and end of the malaria season for 2 consecutive years.

Secondary Outcome Measures

Malaria incidence
Through passive RDT case detection

Full Information

First Posted
July 17, 2012
Last Updated
January 31, 2014
Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
NCHADS - Ministry of Health of Cambodia, Institut Pasteur
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1. Study Identification

Unique Protocol Identification Number
NCT01663831
Brief Title
Repellents as Added Control Measure to Long Lasting Insecticidal Nets
Acronym
MalaResT
Official Title
Repellents as Added Control Measure to Long Lasting Insecticidal Nets to Target the Residual Transmission in Southeast Asia: a Step Forwards to Malaria Elimination
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Tropical Medicine, Belgium
Collaborators
NCHADS - Ministry of Health of Cambodia, Institut Pasteur

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The scaling up of Long Lasting Insecticidal Nets (LLIN) and the expansion of Indoor Residual Spraying (IRS) has contributed to a significant decrease of malaria worldwide. However these control methods tackle only indoor and night biting vectors. The proportion of transmission occurring outdoors and before sleeping hours or so-called "residual transmission" is steadily increasing and may compromise the effort towards malaria elimination. The purpose of this study is to raise evidence on the effectiveness of mass use of topical repellents in addition to LLINs in controlling malaria infections. A multidisciplinary approach will be used to collect information on the most important factors that contribute to the successful reduction of "residual malaria transmission". In a first objective the epidemiological efficacy of repellents on prevalence of malaria carriers and malaria incidence will be assessed. To achieve this goal 98 communities will be randomly assigned to one of two treatment arms (LLIN and LLIN + repellent). Within a community a cross sectional random sample of 65 people will be drawn at the beginning and the end of the malaria season to obtain an estimate of the malaria prevalence. The second objective will handle the entomological efficacy and persistence of the topical repellent on malaria vectors. And lastly the acceptability, adherence and adequacy of the topical repellents will be studied in a third objective.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Outdoor Malaria Transmission, Anopheles, Topical repellent, Early biting vector, Long Lasting Insecticidal Net (LLIN), Cambodia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topical Repellent & LLIN
Arm Type
Experimental
Arm Title
Long Lasting Insecticidal Nets
Arm Type
No Intervention
Arm Description
Brand Name LLIN: Olyset Net Active ingredient: permethrin
Intervention Type
Other
Intervention Name(s)
Mosquito topical repellent
Other Intervention Name(s)
Brand name: Autan, Active ingredient: Icaridin
Intervention Description
Daily repellent use, before and after sleeping hours during the malaria season (6 months) in addition to the use of Long Lasting Insecticidal Nets during sleeping hours.
Primary Outcome Measure Information:
Title
Change from baseline in malaria prevalence at 6 months
Description
Malaria prevalence (PCR detection) will be measured in both study arms at the start and end of the malaria season for 2 consecutive years.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Malaria incidence
Description
Through passive RDT case detection
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All household members volunteering from selected communities Exclusion Criteria: Infants less than 2 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Coosemans, Professor
Organizational Affiliation
Institute of Tropical Medicine Antwerp
Official's Role
Principal Investigator
Facility Information:
City
Banlung
State/Province
Ratanakiri
Country
Cambodia

12. IPD Sharing Statement

Citations:
PubMed Identifier
27371977
Citation
Sluydts V, Durnez L, Heng S, Gryseels C, Canier L, Kim S, Van Roey K, Kerkhof K, Khim N, Mao S, Uk S, Sovannaroth S, Grietens KP, Sochantha T, Menard D, Coosemans M. Efficacy of topical mosquito repellent (picaridin) plus long-lasting insecticidal nets versus long-lasting insecticidal nets alone for control of malaria: a cluster randomised controlled trial. Lancet Infect Dis. 2016 Oct;16(10):1169-1177. doi: 10.1016/S1473-3099(16)30148-7. Epub 2016 Jun 29.
Results Reference
derived
PubMed Identifier
26597653
Citation
Heng S, Durnez L, Gryseels C, Van Roey K, Mean V, Uk S, Siv S, Grietens KP, Sochantha T, Coosemans M, Sluydts V. Assuring access to topical mosquito repellents within an intensive distribution scheme: a case study in a remote province of Cambodia. Malar J. 2015 Nov 24;14:468. doi: 10.1186/s12936-015-0960-4.
Results Reference
derived
PubMed Identifier
24206649
Citation
Canier L, Khim N, Kim S, Sluydts V, Heng S, Dourng D, Eam R, Chy S, Khean C, Loch K, Ken M, Lim H, Siv S, Tho S, Masse-Navette P, Gryseels C, Uk S, Van Roey K, Grietens KP, Sokny M, Thavrin B, Chuor CM, Deubel V, Durnez L, Coosemans M, Menard D. An innovative tool for moving malaria PCR detection of parasite reservoir into the field. Malar J. 2013 Nov 9;12:405. doi: 10.1186/1475-2875-12-405.
Results Reference
derived

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Repellents as Added Control Measure to Long Lasting Insecticidal Nets

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