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Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda

The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial t...

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Autores principales: Lengeler, Christian, Burri, Christian, Awor, Phyllis, Athieno, Prosciova, Kimera, Joseph, Tumukunde, Gloria, Angiro, Irene, Tshefu, Antoinette, Okitawutshu, Jean, Kalenga, Jean-Claude, Omoluabi, Elizabeth, Akano, Babatunde, Ayodeji, Kazeem, Okon, Charles, Yusuf, Ocheche, Brunner, Nina C., Delvento, Giulia, Lee, Tristan, Lambiris, Mark, Visser, Theodoor, Napier, Harriet G., Cohen, Justin M., Buj, Valentina, Signorell, Aita, Hetzel, Manuel W.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10022208/
https://www.ncbi.nlm.nih.gov/pubmed/36962706
http://dx.doi.org/10.1371/journal.pgph.0000464
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author Lengeler, Christian
Burri, Christian
Awor, Phyllis
Athieno, Prosciova
Kimera, Joseph
Tumukunde, Gloria
Angiro, Irene
Tshefu, Antoinette
Okitawutshu, Jean
Kalenga, Jean-Claude
Omoluabi, Elizabeth
Akano, Babatunde
Ayodeji, Kazeem
Okon, Charles
Yusuf, Ocheche
Brunner, Nina C.
Delvento, Giulia
Lee, Tristan
Lambiris, Mark
Visser, Theodoor
Napier, Harriet G.
Cohen, Justin M.
Buj, Valentina
Signorell, Aita
Hetzel, Manuel W.
author_facet Lengeler, Christian
Burri, Christian
Awor, Phyllis
Athieno, Prosciova
Kimera, Joseph
Tumukunde, Gloria
Angiro, Irene
Tshefu, Antoinette
Okitawutshu, Jean
Kalenga, Jean-Claude
Omoluabi, Elizabeth
Akano, Babatunde
Ayodeji, Kazeem
Okon, Charles
Yusuf, Ocheche
Brunner, Nina C.
Delvento, Giulia
Lee, Tristan
Lambiris, Mark
Visser, Theodoor
Napier, Harriet G.
Cohen, Justin M.
Buj, Valentina
Signorell, Aita
Hetzel, Manuel W.
author_sort Lengeler, Christian
collection PubMed
description The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial treatment before referral to a health facility with full case management capabilities. One randomized controlled trial published in 2009 showed a protective effect of RAS pre-referral treatment against overall mortality of 26%, but with significant differences according to study sites and length of referral. Two important issues remained unaddressed: (1) whether the mortality impact of RAS observed under controlled trial conditions could be replicated under real-world circumstances; and (2) clear operational guidance for the wide-scale implementation of RAS, including essential health system determinants for optimal impact. From 2018 to 2020, the Community Access to Rectal Artesunate for Malaria (CARAMAL) project was conducted as a large-scale observational implementation study in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda (registered on ClinicalTrials.gov as NCT03568344). CARAMAL aimed to provide high-quality field evidence on the two issues above, in three remote settings with high malaria endemicity. A number of complementary study components were implemented. The core of the CARAMAL study was the Patient Surveillance System (PSS), which allowed tracking of cases of severe febrile illness from first contact at the periphery to a referral health facility, and then on to a Day 28 visit at the home of the patient. Community and provider cross-sectional surveys complemented the PSS. Here we describe in some detail RAS implementation, as well as the key CARAMAL study components and basic implementation experience. This manuscript does not intend to present key study results, but provides an extensive reference document for the companion papers describing the impact, referral process, post-referral treatment and costing of the RAS intervention.
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spelling pubmed-100222082023-03-17 Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda Lengeler, Christian Burri, Christian Awor, Phyllis Athieno, Prosciova Kimera, Joseph Tumukunde, Gloria Angiro, Irene Tshefu, Antoinette Okitawutshu, Jean Kalenga, Jean-Claude Omoluabi, Elizabeth Akano, Babatunde Ayodeji, Kazeem Okon, Charles Yusuf, Ocheche Brunner, Nina C. Delvento, Giulia Lee, Tristan Lambiris, Mark Visser, Theodoor Napier, Harriet G. Cohen, Justin M. Buj, Valentina Signorell, Aita Hetzel, Manuel W. PLOS Glob Public Health Research Article The key to reducing malaria deaths in highly endemic areas is prompt access to quality case management. Given that many severe cases occur at peripheral level, rectal artesunate (RAS) in the form of suppositories was developed in the 1990s, allowing for rapid initiation of life-saving antimalarial treatment before referral to a health facility with full case management capabilities. One randomized controlled trial published in 2009 showed a protective effect of RAS pre-referral treatment against overall mortality of 26%, but with significant differences according to study sites and length of referral. Two important issues remained unaddressed: (1) whether the mortality impact of RAS observed under controlled trial conditions could be replicated under real-world circumstances; and (2) clear operational guidance for the wide-scale implementation of RAS, including essential health system determinants for optimal impact. From 2018 to 2020, the Community Access to Rectal Artesunate for Malaria (CARAMAL) project was conducted as a large-scale observational implementation study in the Democratic Republic of the Congo (DRC), Nigeria, and Uganda (registered on ClinicalTrials.gov as NCT03568344). CARAMAL aimed to provide high-quality field evidence on the two issues above, in three remote settings with high malaria endemicity. A number of complementary study components were implemented. The core of the CARAMAL study was the Patient Surveillance System (PSS), which allowed tracking of cases of severe febrile illness from first contact at the periphery to a referral health facility, and then on to a Day 28 visit at the home of the patient. Community and provider cross-sectional surveys complemented the PSS. Here we describe in some detail RAS implementation, as well as the key CARAMAL study components and basic implementation experience. This manuscript does not intend to present key study results, but provides an extensive reference document for the companion papers describing the impact, referral process, post-referral treatment and costing of the RAS intervention. Public Library of Science 2022-09-06 /pmc/articles/PMC10022208/ /pubmed/36962706 http://dx.doi.org/10.1371/journal.pgph.0000464 Text en © 2022 Lengeler et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Lengeler, Christian
Burri, Christian
Awor, Phyllis
Athieno, Prosciova
Kimera, Joseph
Tumukunde, Gloria
Angiro, Irene
Tshefu, Antoinette
Okitawutshu, Jean
Kalenga, Jean-Claude
Omoluabi, Elizabeth
Akano, Babatunde
Ayodeji, Kazeem
Okon, Charles
Yusuf, Ocheche
Brunner, Nina C.
Delvento, Giulia
Lee, Tristan
Lambiris, Mark
Visser, Theodoor
Napier, Harriet G.
Cohen, Justin M.
Buj, Valentina
Signorell, Aita
Hetzel, Manuel W.
Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
title Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
title_full Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
title_fullStr Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
title_full_unstemmed Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
title_short Community access to rectal artesunate for malaria (CARAMAL): A large-scale observational implementation study in the Democratic Republic of the Congo, Nigeria and Uganda
title_sort community access to rectal artesunate for malaria (caramal): a large-scale observational implementation study in the democratic republic of the congo, nigeria and uganda
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10022208/
https://www.ncbi.nlm.nih.gov/pubmed/36962706
http://dx.doi.org/10.1371/journal.pgph.0000464
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