Assessing the efficacy of two dual-active ingredients long-lasting insecticidal nets for the control of malaria transmitted by pyrethroid-resistant vectors in Benin: study protocol for a three-arm, single-blinded, parallel, cluster-randomized controlled trial
Open Access
- 19 February 2021
- journal article
- research article
- Published by Springer Science and Business Media LLC in BMC Infectious Diseases
- Vol. 21 (1), 1-12
- https://doi.org/10.1186/s12879-021-05879-1
Abstract
Long-lasting insecticidal nets (LLINs) are currently the primary method of malaria control in sub-Saharan Africa and have contributed to a significant reduction in malaria burden over the past 15 years. However, this progress is threatened by the wide-scale selection of insecticide-resistant malaria vectors. It is, therefore, important to accelerate the generation of evidence for new classes of LLINs. This protocol presents a three-arm superiority, single-blinded, cluster randomized controlled trial to evaluate the impact of 2 novel dual-active ingredient LLINs on epidemiological and entomological outcomes in Benin, a malaria-endemic area with highly pyrethroid-resistant vector populations. The study arms consist of (i) Royal Guard® LLIN, a net combining a pyrethroid (alpha-cypermethrin) plus an insect growth regulator (pyriproxyfen), which in the adult female is known to disrupt reproduction and egg fertility; (ii) Interceptor G2® LLIN, a net incorporating two adulticides (alpha-cypermethrin and chlorfenapyr) with different modes of action; and (iii) the control arm, Interceptor® LLIN, a pyrethroid (alpha-cypermethrin) only LLIN. In all arms, one net for every 2 people will be distributed to each household. Sixty clusters were identified and randomised 1:1:1 to each study arm. The primary outcome is malaria case incidence measured over 24 months through active case detection in a cohort of 25 children aged 6 months to 10 years, randomly selected from each cluster. Secondary outcomes include 1) malaria infection prevalence (all ages) and prevalence of moderate to severe anaemia in children under 5 years old, measured at 6 and 18 months post-intervention; 2) entomological indices measured every 3 months using human landing catches over 24 months. Insecticide resistance intensity will also be monitored over the study period. This study is the second cluster randomised controlled trial to evaluate the efficacy of these next-generation LLINs to control malaria transmitted by insecticide-resistant mosquitoes. The results of this study will form part of the WHO evidence-based review to support potential public health recommendations of these nets and shape malaria control strategies of sub-Saharan Africa for the next decade. ClinicalTrials.gov, NCT03931473, registered on 30 April 2019.Funding Information
- UNITAID & The Global Fund (2018-25 Catalytic LLIN)
This publication has 40 references indexed in Scilit:
- Insecticide resistance profile of Anopheles gambiae from a phase II field station in Cové, southern Benin: implications for the evaluation of novel vector control productsMalaria Journal, 2015
- Insecticidal and sterilizing effect of Olyset Duo®, a permethrin and pyriproxyfen mixture net against pyrethroid-susceptible and -resistant strains ofAnopheles gambiae s.s.: a release-recapture assay in experimental hutsParasite, 2015
- Efficacy of Olyset®Duo, a permethrin and pyriproxyfen mixture net against wild pyrethroid-resistantAnopheles gambiae s.s.from Côte d’Ivoire: an experimental hut trialParasite, 2015
- The activity of the pyrrole insecticide chlorfenapyr in mosquito bioassay: towards a more rational testing and screening of non-neurotoxic insecticides for malaria vector controlMalaria Journal, 2015
- The efficacy of long-lasting nets with declining physical integrity may be compromised in areas with high levels of pyrethroid resistanceMalaria Journal, 2013
- Sterilising effects of pyriproxyfen on Anopheles arabiensis and its potential use in malaria controlParasites & Vectors, 2013
- SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical TrialsAnnals of Internal Medicine, 2013
- Loss of Household Protection from Use of Insecticide-Treated Nets against Pyrethroid-Resistant Mosquitoes, BeninEmerging Infectious Diseases, 2012
- Pyrethroid resistance in African anopheline mosquitoes: what are the implications for malaria control?Trends in Parasitology, 2011
- Insecticidal Action and Mitochondrial Uncoupling Activity of AC-303,630 and Related Halogenated PyrrolesPesticide Biochemistry and Physiology, 1994