To assess whether addition of pyriproxyfen to long-lasting insecticidal mosquito nets increases their durability compared to standard long-lasting insecticidal mosquito nets
| ISRCTN | ISRCTN30634670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30634670 |
| Secondary identifying numbers | v1.0 |
- Submission date
- 08/07/2014
- Registration date
- 13/08/2014
- Last edited
- 17/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
School of Biological & Biomedical Sciences
Durham University
Durham
DH1 3LE
United Kingdom
| Phone | +44 (0)191 334 1291 |
|---|---|
| S.W.Lindsay@durham.ac.uk |
Study information
| 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 |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Pyriproxyfen combined with permethrin on bednets will be just as durable as standard permethrin-treated nets. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/03/2014 |
| Completion date | 30/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | Approximately 1500 subjects |
| Key inclusion criteria | 1. Village residents who sleep in a bed 2. Those that provide their informed consent to participate in the trial |
| Key exclusion criteria | 1. Non-residents 2. Residents who do not sleep in a bed 3. Those that do not provide their informed consent |
| Date of first enrolment | 01/03/2014 |
| Date of final enrolment | 30/05/2017 |
Locations
Countries of recruitment
- Burkina Faso
- England
- United Kingdom
Study participating centre
DH1 3LE
United Kingdom
Sponsor information
University/education
c/o Prof Jon Davidson
Faculty of Science
Durham University
Durham
DH1 3LE
England
United Kingdom
| Phone | +44 (0)191 334 2328 |
|---|---|
| j.p.davidson@durham.ac.uk | |
"ROR" |
https://ror.org/01v29qb04 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 28/04/2015 | Yes | No | |
| Results article | results: | 18/08/2018 | Yes | No |
Editorial Notes
17/08/2018: Publication reference added
