Condition category
Infections and Infestations
Date applied
18/04/2012
Date assigned
30/04/2012
Last edited
08/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vincent Corbel

ORCID ID

Contact details

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

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 December 2010

Study design

Cluster randomized controlled trial with 18 months follow-up

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

Not Applicable

Drug names

Primary outcome measures

Incidence density rates of Plasmodium falciparum clinicalmalaria in children under 6 years

Secondary outcome measures

1. The prevalence and parasite density of asymptomatic infections among children 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

Eligibility

Participant inclusion criteria

1. Children aged 0-71 months
2. Lives in villages selected for study

Participant type

Patient

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

http://en.ird.fr/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22682536

Publication citations

  1. 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.

Additional files

Editorial Notes