دورية أكاديمية
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.
| العنوان: | 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. |
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| المؤلفون: | Foy BD; Center for Vector-Borne Infectious Diseases, Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, United States., Some A; Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso., Magalhaes T; Department of Entomology, Texas A&M University, College Station, TX, United States.; Department of Preventive and Social Medicine, School of Medicine, Universidade Federal da Bahia, Salvador, Brazil., Gray L; Center for Vector-Borne Infectious Diseases, Department of Microbiology, Immunology and Pathology, Colorado State University, Fort Collins, CO, United States., Rao S; Department of Clinical Sciences, Colorado State University, Fort Collins, CO, United States., Sougue E; Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso., Jackson CL; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, United States., Kittelson J; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO, United States., Slater HC; Malaria and Neglected Tropical Diseases, Program for Appropriate Technology in Health, Seattle, WA, United States., Bousema T; Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands., Da O; Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso., Coulidiaty AGV; Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso., Colt M; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States., Wade M; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States., Richards K; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States., Some AF; Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso., Dabire RK; Institut de Recherche en Sciences de la Santé, Direction Régionale de l'Ouest, Bobo-Dioulasso, Burkina Faso., Parikh S; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States. |
| المصدر: | JMIR research protocols [JMIR Res Protoc] 2023 Mar 20; Vol. 12, pp. e41197. Date of Electronic Publication: 2023 Mar 20. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: JMIR Publications Country of Publication: Canada NLM ID: 101599504 Publication Model: Electronic Cited Medium: Print ISSN: 1929-0748 (Print) Linking ISSN: 19290748 NLM ISO Abbreviation: JMIR Res Protoc Subsets: PubMed not MEDLINE |
| أسماء مطبوعة: | Original Publication: Toronto : JMIR Publications |
| مستخلص: | Background: The gains made against malaria have stagnated since 2015, threatened further by increasing resistance to insecticides and antimalarials. Improvement in malaria control necessitates a multipronged strategy, which includes the development of novel tools. One such tool is mass drug administration (MDA) with endectocides, primarily ivermectin, which has shown promise in reducing malaria transmission through lethal and sublethal impacts on the mosquito vector. Objective: The primary objective of the study is to assess the impact of repeated ivermectin MDA on malaria incidence in children aged ≤10 years. Methods: Repeat Ivermectin MDA for Malaria Control II is a double-blind, placebo-controlled, cluster-randomized, and parallel-group trial conducted in a setting with intense seasonal malaria transmission in Southwest Burkina Faso. The study included 14 discrete villages: 7 (50%) randomized to receive standard measures (seasonal malaria chemoprevention [SMC] and bed net use for children aged 3 to 59 months) and placebo, and 7 (50%) randomized to receive standard measures and monthly ivermectin MDA at 300 μg/kg for 3 consecutive days, provided under supervision to all eligible village inhabitants, over 2 successive rainy seasons. Nonpregnant individuals >90 cm in height were eligible for ivermectin MDA, and cotreatment with ivermectin and SMC was not permitted. The primary outcome is malaria incidence in children aged ≤10 years, as assessed by active case surveillance. The secondary safety outcome of repeated ivermectin MDA was assessed through active and passive adverse event monitoring. Results: The trial intervention was conducted from July to November in 2019 and 2020, with additional sampling of humans and mosquitoes occurring through February 2022 to assess postintervention changes in transmission patterns. Additional human and entomological assessments were performed over the 2 years in a subset of households from 6 cross-sectional villages. A subset of individuals underwent additional sampling in 2020 to characterize ivermectin pharmacokinetics and pharmacodynamics. Analysis and unblinding will commence once the database has been completed, cleaned, and locked. Conclusions: Our trial represents the first study to directly assess the impact of a novel approach for malaria control, ivermectin MDA as a mosquitocidal agent, layered into existing standard-of-care interventions. The study was designed to leverage the current SMC deployment infrastructure and will provide evidence regarding the additional benefit of ivermectin MDA in reducing malaria incidence in children. Trial Registrations: ClinicalTrials.gov NCT03967054; https://clinicaltrials.gov/ct2/show/NCT03967054 and Pan African Clinical Trials Registry PACT201907479787308; https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=8219. International Registered Report Identifier (irrid): DERR1-10.2196/41197. (©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. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.03.2023.) |
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| فهرسة مساهمة: | Keywords: Anopheles; clinical trial; cluster-randomized; endectocide; ivermectin; malaria; mass drug administration; mosquito; seasonal malaria chemoprevention; transmission |
| سلسلة جزيئية: | ClinicalTrials.gov NCT03967054 |
| تواريخ الأحداث: | Date Created: 20230320 Latest Revision: 20230428 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC10132043 |
| DOI: | 10.2196/41197 |
| PMID: | 36939832 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1929-0748 |
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| DOI: | 10.2196/41197 |