Plain English Summary
Background and study aims
Malaria is a serious tropical disease spread by mosquitoes. Recent reductions in malaria in sub-Saharan Africa have been associated with the increased use of pyrethroid-treated long-lasting insecticidal nets (LLINs). Pyrethroids are currently the only class of insecticide used for treating nets, and the rapid increase in resistance to pyrethroids in mosquitoes may jeopardise future mosquito control. Nets containing a new combination of permethrin and pyriproxyfen (PPF-LLIN) may enhance malaria control and reduce the spread of pyrethroid-resistant mosquitoes. This study will determine whether PPF-LLINs provide better protection against malaria than LLINs in an area with pyrethroid-resistant mosquitoes.
Who can participate?
Children resident in Burkina Faso, aged 6 months to 5 years old.
What does the study involve?
Participants will be provided with LLINs at the start of the study, and their previous nets will be removed. The LLINs will be gradually exchanged for PPF-LLINs so that at three months before the end of the two-year study all participants will have a PPF-LLIN.
What are the possible benefits and risks of participating?
Study children will benefit from a health check at the surveys and all participants will benefit from the health facility clinical services which will be supported by training and the presence of study nurses in addition to government staff. There are no apparent risks to the safety of individuals or communities in the use of the conventional nets. Permethrin-treated long-lasting nets have been fully evaluated by the WHO Pesticide Evaluation Scheme (WHOPES) and approved for mosquito control. However, PPF-LLINs have not previously been evaluated in the field before, apart from small-scale studies. Whilst we do not anticipate any serious impacts of the combination of permethrin and PPF, since the safety profile of both these active compounds is deemed acceptable by WHOPES, we cannot exclude the possibility that there might be side effects when using the combination. For this reason it is important to assess adverse events and especially any serious adverse events in study subjects during the course of the study to determine whether there is an excess of side effects associated with the PPF-LLINs.
Where is the study run from?
Durham University (UK)
When is the study starting and how long is it expected to run for?
May 2014 to May 2015
Who is funding the study?
EC Seventh Framework Programme
Who is the main contact?
Prof Steve Lindsay
S.W.Lindsay@durham.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Steve Lindsay
ORCID ID
Contact details
School of Biological and Biomedical Sciences
Science Laboratories
South Road
Durham
DH13LE
United Kingdom
+44 (0)191 334 1291
S.W.Lindsay@durham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2013-02-011
Study information
Scientific title
To assess whether addition of a second insecticide to long-lasting insecticidal mosquito nets provides additional protection against clinical malaria over current best practice. Protocol for a two-armed cluster randomized wedge-shaped trial in Burkina Faso
Acronym
Study hypothesis
Our hypothesis is that mosquito nets treated with two insecticides will provide significant incremental protection against malaria than pyrethroid-treated nets in an area with moderate levels of pyrethroid resistance.
Ethics approval
1. Comite d’ethique pour la recherché en sante, Ministere de la recherché scientifique et de l’innovation, Burkina Faso, 13/05/2014, ref: 2014-3-24
2. School of Biological and Biomedical Ethics Committee, Durham University, UK, 17/01/2014
Study design
Two-armed cluster randomized wedge-shaped trial
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 use the contact details below to request a patient information sheet
Condition
Malaria
Intervention
Long-lasting insecticidal mosquito nets (LLINs) and new net.
Long-lasting insecticidal mosquito nets (LLINs)
The LLINs distributed will be manufactured by Sumitomo Chemical Company. These LLINs are WHO recommended and meets WHO specifications (http://www.who.int/whopes/Long_lasting_insecticidal_nets_Aug09.pdf) with 2% w/w permethrin incorporated into polyethylene fibres giving adequate release of permethrin for about five years. These nets will be distributed in May 2013, at the beginning of the main transmission season, at no cost to the recipients. We will use white 'extra family' size rectangular nets (180cm wide x 190cm l x 150 cm h) throughout. Government Roll Back Malaria information, education and communication procedures will be followed to encourage correct net use and maintenance. This will include supplying the nets in individual pre-opened bags labelled by the manufacturers.
A new net with two insecticides will be provided by Sumitomo Chemicals and are currently undergoing evaluation by the WHO Pesticide Evaluation Scheme (WHOPES). The nets contain 2% w/w permethrin and another insecticide incorporated into polyethylene fibres giving adequate release of both insecticides for an estimated three years. We will provide white 'extra family' size rectangular nets (180cm wide x 190cm l x 150 cm h) throughout. The new nets will be supplied in individual bags labelled by the manufacturers and they will be distributed to recipients in pre-opened individual sachets in August 2013 in five village clusters and rolled out in a wedge-shaped design at monthly intervals thereafter during the main transmission seasons in 2013 and 2014.
New net distribution will be carried out by the study team in a similar manner to the LLINs.
Intervention type
Device
Phase
Drug names
Primary outcome measure
To assess whether a pyrethroid insecticide combined with another class of insecticide incorporated into a LLIN provides added protection against clinical malaria in children compared with pyrethroid-only LLINs (LLIN) over two malaria transmission seasons of follow up.
Secondary outcome measures
Efficacy
1. To assess whether two insecticides on LLINs provide added protection compared to LLINs against anaemia and/or parasite prevalence in children.
2. To assess and compare the prevalence of microscopy confirmed gametocyte carriers (GC) in LLINs group versus doublke insecticide-LLIN group.
Safety
To assess whether the double-insecticide LLINs have a safety profile comparable with LLINs in the trial population
Overall trial start date
01/05/2013
Overall trial end date
31/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Resident children, aged 6 months to 5 years old will be enumerated and an average of 50 per cluster (range 30-100, depending on village size) will be selected randomly, stratified by age and invited to participate in the clinical surveys and passive case detection (PCD). No distinctions will be made regarding gender, ethnic group, medical condition or physical health.
As is customary in Burkina Faso, sensitisation will start by discussions with community elders and then representatives of the whole study community in order to explain the nature of the study and what will be required during the interventions and investigations. Informed consent will be sought at the village level after sensitization meetings attended by village community leaders and health staff. The key attendees names and roles will be documented for each village. Witnessed written consent will be sought from each net recipient, before net donation and exchange. We will seek written consent from room owners before positioning of mosquito traps, and written informed consent from the parents or caregivers of all enrolled study children. During these procedures it will be made clear that people will be able to leave the study at any time but their original net will not be returned.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
2000
Participant exclusion criteria
Those who have not provided their consent for inclusion in the study
Recruitment start date
01/05/2014
Recruitment end date
01/05/2015
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
Durham University
School of Biological and Biomedical Sciences
Science Laboratories
South Road
Durham
DH13LE
United Kingdom
Sponsor information
Organisation
Durham University (UK)
Sponsor details
c/o Professor Andrew Deeks
Pro-Vice Chancellor of Science
School of Engineering and Computing Sciences
South Road
Durham
DH13LE
United Kingdom
+44 (0)191 334 1017
pvc.science@durham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873089