Repeat Ivermectin Mass Drug Administrations for Malaria Control II: Protocol for a Double-blind, Cluster-Randomized, Placebo-Controlled Trial for the Integrated Control of Malaria (Preprint)

• DOI: 10.2196/preprints.41197
• Publication Date: 2022-07-22T16:37:35Z
• Authors: Brian D Foy; Anthony Some; Tereza Magalhaes; Lyndsey Gray; Sangeeta Rao; Emmanuel Sougue; Conner L Jackson; John Kittelson; Hannah C Slater; Teun Bousema; Ollo Da; A Gafar V Coulidiaty; McKenzie Colt; Martina Wade; Kacey Richards; A Fabrice Some; Roch K Dabire; Sunil Parikh
• Keywords: Preprint; Mass drug administration; Placebo-controlled study

<sec> <title>BACKGROUND</title> The gains made against malaria have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in control necessitates a multipronged strategy, which includes the development of novel tools. One such tool is mass drug administration (MDA) with endectocides, primarily ivermectin, has shown promise reducing transmission through lethal sublethal impacts on mosquito vector. </sec> <title>OBJECTIVE</title> primary objective study assess impact repeated ivermectin MDA incidence children aged ≤10 years. <title>METHODS</title> Repeat Ivermectin for Malaria Control II double-blind, placebo-controlled, cluster-randomized, parallel-group trial conducted setting intense seasonal Southwest Burkina Faso. included 14 discrete villages: 7 (50%) randomized receive standard measures (seasonal chemoprevention [SMC] bed net use 3 59 months) placebo, monthly at 300 μg/kg consecutive days, provided under supervision all eligible village inhabitants, over 2 successive rainy seasons. Nonpregnant individuals &amp;gt;90 cm height were MDA, cotreatment SMC was not permitted. outcome years, as assessed active case surveillance. secondary safety passive adverse event monitoring. <title>RESULTS</title> intervention from July November 2019 2020, additional sampling humans mosquitoes occurring February 2022 postintervention changes patterns. Additional human entomological assessments performed years subset households 6 cross-sectional villages. A underwent 2020 characterize pharmacokinetics pharmacodynamics. Analysis unblinding will commence once database been completed, cleaned, locked. <title>CONCLUSIONS</title> Our represents first directly approach control, mosquitocidal agent, layered into existing standard-of-care interventions. designed leverage current deployment infrastructure provide evidence regarding benefit children. <title>CLINICALTRIAL</title> ClinicalTrials.gov NCT03967054; https://clinicaltrials.gov/ct2/show/NCT03967054; Pan African Clinical Trials Registry PACT201907479787308 <title>INTERNATIONAL REGISTERED REPORT</title> DERR1-10.2196/41197