Entomological research, training and prevention strategies for malaria in Africa

ISRCTN ISRCTN07404145
DOI https://doi.org/10.1186/ISRCTN07404145
Secondary identifying numbers FSP project 2006-22
Submission date
18/04/2012
Registration date
30/04/2012
Last edited
24/04/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Vincent Corbel
Scientific

Institut de Recherche pour le Développement/Centre de Recherche Entomologique de Cotonou (IRD/CREC)
Quartier les cocotiers
Près de la direction générale des impôts
01 BP 4414 RP
Cotonou
00229
Benin

Study information

Study designCluster randomized controlled trial with 18 months follow-up
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Home
Study typePrevention
Participant information sheet Not available in web format, please contact Georgia Bakiri (barikiss2000@yahoo.fr) to request a patient information sheet
Scientific titleCombining vector control interventions for malaria control in pyrethroid resistance area: a cluster randomized controlled trial in Benin, West Africa
Study objectivesThe 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(s)National Ethical Committee for Medical Research (CNPERS), Benin, 16/12/2010
Health condition(s) or problem(s) studiedMalaria prevention by vector control strategies
InterventionFour 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 typeOther
Primary outcome measureIncidence density rates of Plasmodium falciparum clinical malaria in children aged under 6 years
Secondary outcome measures1. 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 study start date09/07/2008
Completion date23/12/2009

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit0 Months
Upper age limit71 Months
SexBoth
Target number of participants4 arms of 7 villages each with overall 1126 children aged 0-71 months
Key inclusion criteria1. Children aged 0-71 months
2. Lives in villages selected for study
Key exclusion criteria1. Inhabitants older than 6 years
2. Children not living in selected villages
Date of first enrolment09/07/2008
Date of final enrolment23/12/2009

Locations

Countries of recruitment

  • Benin

Study participating centre

Institut de Recherche pour le Développement/Centre de Recherche Entomologique de Cotonou (IRD/CREC)
Cotonou
00229
Benin

Sponsor information

Institute of Development Research [Institut de Recherche pour le Développement] (France)
Government

Centre de Recherche Entomologique de Cotonou (CREC)
Quartier les cocotiers
Près de la direction générale des impôts
01 BP 4414 RP
Cotonou
00229
Benin

Website http://en.ird.fr/
ROR logo "ROR" https://ror.org/032qezt74

Funders

Funder type

Government

Ministry of Foreign and European Affairs (France) ref: FSP project 2006-22

No information available

Institute of Development Research [Institut de Recherche pour le Développement] (France)

No information available

President'’s Malaria Initiative (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2012 Yes No

Editorial Notes

24/04/2017: Plain English summary added.