Cargando…
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
BACKGROUND: Residual 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 intermi...
| Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BioMed Central
2023
|
| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942013/ https://www.ncbi.nlm.nih.gov/pubmed/36810194 http://dx.doi.org/10.1186/s13063-023-07098-2 |
| _version_ | 1784891400106541056 |
|---|---|
| author | Chaccour, Carlos Casellas, Aina Hammann, Felix Ruiz-Castillo, Paula Nicolas, Patricia Montaña, Julia Mael, Mary Selvaraj, Prashant Duthaler, Urs Mrema, Sigilbert Kakolwa, Mwaka Lyimo, Issa Okumu, Fredros Marathe, Achla Schürch, Roger Elobolobo, Eldo Sacoor, Charfudin Saute, Francisco Xia, Kang Jones, Caroline Rist, Cassidy Maia, Marta Rabinovich, N. Regina |
| author_facet | Chaccour, Carlos Casellas, Aina Hammann, Felix Ruiz-Castillo, Paula Nicolas, Patricia Montaña, Julia Mael, Mary Selvaraj, Prashant Duthaler, Urs Mrema, Sigilbert Kakolwa, Mwaka Lyimo, Issa Okumu, Fredros Marathe, Achla Schürch, Roger Elobolobo, Eldo Sacoor, Charfudin Saute, Francisco Xia, Kang Jones, Caroline Rist, Cassidy Maia, Marta Rabinovich, N. Regina |
| author_sort | Chaccour, Carlos |
| collection | PubMed |
| description | BACKGROUND: Residual 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. METHODS: A 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 RDTs DISCUSSION: The 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 transmission TRIAL REGISTRATION: ClinicalTrials.govNCT04966702. Registered on July 19, 2021. Pan African Clinical Trials Registry PACTR202106695877303. |
| format | Online Article Text |
| id | pubmed-9942013 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2023 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-99420132023-02-21 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 Chaccour, Carlos Casellas, Aina Hammann, Felix Ruiz-Castillo, Paula Nicolas, Patricia Montaña, Julia Mael, Mary Selvaraj, Prashant Duthaler, Urs Mrema, Sigilbert Kakolwa, Mwaka Lyimo, Issa Okumu, Fredros Marathe, Achla Schürch, Roger Elobolobo, Eldo Sacoor, Charfudin Saute, Francisco Xia, Kang Jones, Caroline Rist, Cassidy Maia, Marta Rabinovich, N. Regina Trials Study Protocol BACKGROUND: Residual 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. METHODS: A 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 RDTs DISCUSSION: The 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 transmission TRIAL REGISTRATION: ClinicalTrials.govNCT04966702. Registered on July 19, 2021. Pan African Clinical Trials Registry PACTR202106695877303. BioMed Central 2023-02-21 /pmc/articles/PMC9942013/ /pubmed/36810194 http://dx.doi.org/10.1186/s13063-023-07098-2 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| spellingShingle | Study Protocol Chaccour, Carlos Casellas, Aina Hammann, Felix Ruiz-Castillo, Paula Nicolas, Patricia Montaña, Julia Mael, Mary Selvaraj, Prashant Duthaler, Urs Mrema, Sigilbert Kakolwa, Mwaka Lyimo, Issa Okumu, Fredros Marathe, Achla Schürch, Roger Elobolobo, Eldo Sacoor, Charfudin Saute, Francisco Xia, Kang Jones, Caroline Rist, Cassidy Maia, Marta Rabinovich, N. Regina 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9942013/ https://www.ncbi.nlm.nih.gov/pubmed/36810194 http://dx.doi.org/10.1186/s13063-023-07098-2 |
| work_keys_str_mv | AT chaccourcarlos bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT casellasaina bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT hammannfelix bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT ruizcastillopaula bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT nicolaspatricia bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT montanajulia bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT maelmary bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT selvarajprashant bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT duthalerurs bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT mremasigilbert bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT kakolwamwaka bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT lyimoissa bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT okumufredros bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT maratheachla bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT schurchroger bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT eloboloboeldo bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT sacoorcharfudin bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT sautefrancisco bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT xiakang bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT jonescaroline bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT ristcassidy bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT maiamarta bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings AT rabinovichnregina bohemiabroadonehealthendectocidebasedmalariainterventioninafricaaphaseiiiclusterrandomizedopenlabelclinicaltrialtostudythesafetyandefficacyofivermectinmassdrugadministrationtoreducemalariatransmissionintwoafricansettings |