BOHEMIA: Broad One Health Endectocide-based Malaria Intervention in Africa—a phase III cluster-randomized, open-label, clinical trial to study the safety and efficacy of ivermectin mass drug administration to reduce malaria transmission in two African settings

Trials

Study Protocol

Prashant Selvaraj¹  Eldo Elobolobo²  Charfudin Sacoor²  Francisco Saute²  Paula Ruiz-Castillo³  Julia Montaña³  Mary Mael³  Aina Casellas³  Patricia Nicolas³  N. Regina Rabinovich⁴  Carlos Chaccour⁵  Mwaka Kakolwa⁶  Issa Lyimo⁶  Sigilbert Mrema⁶  Fredros Okumu⁶  Caroline Jones⁷  Marta Maia⁷  Urs Duthaler⁸  Felix Hammann⁹  Achla Marathe^1,10  Cassidy Rist^1,11  Roger Schürch^1,11  Kang Xia^1,11 

[1] Bill and Melinda Gates Foundation, Seattle, USA;Centro de Investigação em Saúde de Manhiça, Manhica, Mozambique;ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain;ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain;TH Chan Harvard School of Public Health, Boston, USA;ISGlobal, Barcelona Institute for Global Health, Barcelona, Spain;Universidda de Navarra, Pamplona, Spain;Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Madrid, Spain;Ifakara Health Institute, Ifakara, Tanzania;KEMRI Wellcome Trust Research Programme, Kilifi, Kenya;University Basel, Basel, Switzerland;University Hospital of Bern, Inselspital, Bern, Switzerland;University of Virginia, Charlottesville, USA;Virginia Polytechnic Institute and State University, Blacksburg, USA;

关键词: Malaria;    Ivermectin;    Endectocides;    Cluster-randomized;    Mozambique;   

DOI  :  10.1186/s13063-023-07098-2

 received in 2022-11-19, accepted in 2023-01-17,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundResidual malaria transmission is the result of adaptive mosquito behavior that allows malaria vectors to thrive and sustain transmission in the presence of good access to bed nets or insecticide residual spraying. These behaviors include crepuscular and outdoor feeding as well as intermittent feeding upon livestock. Ivermectin is a broadly used antiparasitic drug that kills mosquitoes feeding on a treated subject for a dose-dependent period. Mass drug administration with ivermectin has been proposed as a complementary strategy to reduce malaria transmission.MethodsA cluster randomized, parallel arm, superiority trial conducted in two settings with distinct eco-epidemiological conditions in East and Southern Africa. There will be three groups: human intervention, consisting of a dose of ivermectin (400 mcg/kg) administered monthly for 3 months to all the eligible population in the cluster (>15 kg, non-pregnant and no medical contraindication); human and livestock intervention, consisting human treatment as above plus treatment of livestock in the area with a single dose of injectable ivermectin (200 mcg/kg) monthly for 3 months; and controls, consisting of a dose of albendazole (400 mg) monthly for 3 months. The main outcome measure will be malaria incidence in a cohort of children under five living in the core of each cluster followed prospectively with monthly RDTsDiscussionThe second site for the implementation of this protocol has changed from Tanzania to Kenya. This summary presents the Mozambique-specific protocol while the updated master protocol and the adapted Kenya-specific protocol undergo national approval in Kenya. BOHEMIA will be the first large-scale trial evaluating the impact of ivermectin-only mass drug administration to humans or humans and cattle on local malaria transmissionTrial registrationClinicalTrials.govNCT04966702. Registered on July 19, 2021.Pan African Clinical Trials Registry PACTR202106695877303.

【 授权许可】

CC BY   
© The Author(s) 2023