Plain English Summary
Background and study aims
Malaria is a serious tropical disease caused by a type of parasite known as Plasmodium that is spread by mosquitoes. Malaria can be prevented by sleeping under a mosquito net treated with insecticide (long lasting insecticidal mosquito nets [LLINs]), by applying insecticide to the inside of dwellings (indoor residual spraying [IRS]), or by covering the walls with plastic sheeting treated with carbamate insecticide (CTPS). However, efforts to control and eliminate malaria in Africa are being challenged by parasites becoming resistant to antimalarial drugs and mosquitoes becoming resistant to insecticides. The aim of this study is to find out whether combinations of LLINs and IRS or an IRS-like treatment (CTPS) are more effective at protecting against malaria than LLINs alone.
Who can participate?
Children aged 0-71 months living in the 28 selected villages
What does the study involve?
Participants are randomly allocated to use one of four malaria prevention strategies:
1. LLINs for pregnant women and children aged under 6
2. LLINs to cover all sleeping units
3. LLINs for pregnant women and children aged under 6 and full coverage with carbamate-IRS
4. LLINs to cover all sleeping units and full coverage with CTPS
Malaria infection rates are compared between the four groups.
What are the possible benefits and risks of participating?
Using a combination of LLINs and IRS could be more effective at reducing malaria-related illness.
Where is the study run from?
The health district of Ouidah-Kpomassè-Tori Bossito (OKT) (Benin)
When is the study starting and how long is it expected to run for?
July 2008 to December 2009
Who is funding the study?
1. Ministry of Foreign and European Affairs (France)
2. Institute of Development Research [Institut de Recherche pour le Développement] (France)
3. The President’s Malaria Initiative (PMI) (USA)
Who is the main contact?
Dr Vincent Corbel
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FSP project 2006-22
Study information
Scientific title
Combining vector control interventions for malaria control in pyrethroid resistance area: a cluster randomized controlled trial in Benin, West Africa
Acronym
Study hypothesis
The combination of long lasting insecticidal mosquito nets (LLIN) and indoor residual spraying (IRS) or an IRS-like treatment (i.e. carbamate treated plastic sheeting, CTPS) confer protection against malaria and better management of pyrethroid-resistance in vectors than LLIN alone.
Ethics approval
National Ethical Committee for Medical Research (CNPERS), Benin, 16/12/2010
Study design
Cluster randomized controlled trial with 18 months follow-up
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Home
Trial type
Prevention
Patient information sheet
Not available in web format, please contact Georgia Bakiri (barikiss2000@yahoo.fr) to request a patient information sheet
Condition
Malaria prevention by vector control strategies
Intervention
Four malaria vector control interventions were evaluated as follows:
1. LLIN-targeted coverage [TLLIN] to pregnant women and children <6 years that served as a control group
2. LLIN-universal coverage of all sleeping units [ULLIN]
3. LLIN-targeted coverage to pregnant women and children <6 plus full coverage of Carbamate-IRS [TLLIN+IRS]
4. LLIN-universal coverage of sleeping units plus full coverage of CTPS lined up to the walls of the household [ULLIN+CTPS]
Intervention type
Other
Phase
Drug names
Primary outcome measure
Incidence density rates of Plasmodium falciparum clinical malaria in children aged under 6 years
Secondary outcome measures
1. The prevalence and parasite density of asymptomatic infections among children aged under 6 years
2. The entomological inoculation rates [(EIR), as defined by the number of infected bites per human per year]
3. The human biting rates [(HBR), as defined by the number of bites per human per year]
4. The prevalence of pyrethroid resistant 1014F kdr allele in malaria vectors
Overall trial start date
09/07/2008
Overall trial end date
23/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children aged 0-71 months
2. Lives in villages selected for study
Participant type
Other
Age group
Child
Gender
Both
Target number of participants
4 arms of 7 villages each with overall 1126 children aged 0-71 months
Participant exclusion criteria
1. Inhabitants older than 6 years
2. Children not living in selected villages
Recruitment start date
09/07/2008
Recruitment end date
23/12/2009
Locations
Countries of recruitment
Benin
Trial participating centre
Institut de Recherche pour le Développement/Centre de Recherche Entomologique de Cotonou (IRD/CREC)
Cotonou
00229
Benin
Sponsor information
Organisation
Institute of Development Research [Institut de Recherche pour le Développement] (France)
Sponsor details
Centre de Recherche Entomologique de Cotonou (CREC)
Quartier les cocotiers
Près de la direction générale des impôts
01 BP 4414 RP
Cotonou
00229
Benin
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Ministry of Foreign and European Affairs (France) ref: FSP project 2006-22
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Institute of Development Research [Institut de Recherche pour le Développement] (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
President's Malaria Initiative (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22682536
Publication citations
-
Results
Corbel V, Akogbeto M, Damien GB, Djenontin A, Chandre F, Rogier C, Moiroux N, Chabi J, Banganna B, Padonou GG, Henry MC, Combination of malaria vector control interventions in pyrethroid resistance area in Benin: a cluster randomised controlled trial., Lancet Infect Dis, 2012, 12, 8, 617-626, doi: 10.1016/S1473-3099(12)70081-6.