Plain English Summary
Background and study aims
Malaria is a major cause of sickness and death in sub-Saharan Africa. Sleeping under an effective and long-lasting insecticidal net will protect people from malaria. Pyrethroid-treated bed nets are one of the major mosquito control methods used against malaria in sub-Saharan Africa. However, there are few places where vector mosquitoes (those that can cause malaria) are fully vulnerable to pyrethroid insecticides, so alternative treatments for nets are required urgently. Here we assess the durability of nets with a new combination of insecticides called permethrin and pyriproxyfen in comparison with a typical permethrin-treated net.
Who can participate?
Village residents who usually sleep on a bed can take part in this study.
What does the study involve?
Participating households in each village will be randomly allocated to receive either permethrin and pyriproxyfen treated nets or permethrin-treated nets. We will distribute the nets at the start of the transmission season and follow net use at the start and end of the transmission season, i.e. from 0 to 36 months after distribution. The effectiveness of the insecticide, chemical content along with net durability and fabric integrity will be recorded immediately after distribution, and then at 6, 12, 18, 24, 30 and 36 months. Routine measurements of indoor temperature and relative humidity will be made in both villages during the study. Residents will be followed for possible side effects of the permethrin and pyriproxyfen treated nets by looking for known asthmatic people during the first month after distribution and pregnancy outcomes will be monitored from antenatal clinic records.
What are the possible benefits and risks of participating?
The results from this study will be of interest to those working on malaria control in Burkina Faso and other African countries. Although permethrin and pyriproxyfen are safe to humans, they have not been used together on a mosquito net before. For this reason we will monitor any side effects from both the combination nets and the nets just with permethrin.
Where is the study run from?
This study is run from two villages in Burkina Faso.
When is the study starting and how long is it expected to run for?
The study started in March 2014 and runs until May 2017.
Who is funding the study?
Innovative Vector Control Consortium (UK).
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 & Biomedical Sciences
Durham University
Durham
DH1 3LE
United Kingdom
+44 (0)191 334 1291
S.W.Lindsay@durham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v1.0
Study information
Scientific title
To assess whether addition of pyriproxyfen to long-lasting insecticidal mosquito nets increases their durability compared to standard long-lasting insecticidal mosquito nets: protocol for a cluster randomized study
Acronym
Study hypothesis
Pyriproxyfen combined with permethrin on bednets will be just as durable as standard permethrin-treated nets.
Ethics approval
1. Ethics Committee for Health Research (Comité d'Ethique pour la Recherche en Santé), 02/05/2014, ref: 2014-0-025
2. National Centre for Research and Training on Malaria (Centre National de Recherche et de Formation sur le Paludisme), 27/03/2014, ref. 2014/025/MS/SG/CNRFP/CIB
Study design
Cluster randomized controlled trial of net durability, with clustering at the level of the compound with entomological outcome measurements.
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Durability of mosquito nets
Intervention
Two villages will take part in the trial. The compounds within each village will be randomly allocated to receive one of two types of bednets on a 50/50 basis
Control bednet: Olyset net with 2% w/w permethrin incorporated into polyethylene fibres
Intervention bednet: DUO net which contains 2% w/w permethrin and 1% w/w pyriproxyfen incorporated into polyethylene fibres.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Bio-efficacy is either measured as:
1. Percentage adult female mortality 24 hours after exposure to netting
2. Percentage of viable offspring (1st or 2nd stage larvae) relative to the control group
This will be recorded immediately after net distribution and at 6, 12, 18, 24, 30 and 36 months.
Secondary outcome measures
Proportion of nets in 'poor' condition, defined as:
1. Those that are not long enough to be tucked under the mattress
2. Torn or badly damaged
3. Has more than five holes (finger-width, approximate diameter 2 cm)
All outcomes will be measured at 0 weeks, 6, 12, 18, 24, 30 and 36 months.
Overall trial start date
01/03/2014
Overall trial end date
30/05/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Village residents who sleep in a bed
2. Those that provide their informed consent to participate in the trial
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Approximately 1500 subjects
Participant exclusion criteria
1. Non-residents
2. Residents who do not sleep in a bed
3. Those that do not provide their informed consent
Recruitment start date
01/03/2014
Recruitment end date
30/05/2017
Locations
Countries of recruitment
Burkina Faso
Trial participating centre
Durham University
Durham
DH1 3LE
United Kingdom
Sponsor information
Organisation
Durham University (UK)
Sponsor details
c/o Prof Jon Davidson
Faculty of Science
Durham University
Durham
DH1 3LE
United Kingdom
+44 (0)191 334 2328
j.p.davidson@durham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Innovative Vector Control Consortium (UK)
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
2018 results: https://www.ncbi.nlm.nih.gov/pubmed/30104047
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25927378