Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial.
In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability.This study compar...
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ftdoajarticles:oai:doaj.org/article:ed907d00b6e64e2c9854e9ccaadd97e6 2023-05-15T15:13:55+02:00 Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. Iran Mendonça-da-Silva Antônio Magela Tavares Jacqueline Sachett José Felipe Sardinha Lilian Zaparolli Maria Fátima Gomes Santos Marcus Lacerda Wuelton Marcelo Monteiro 2017-11-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0006068 https://doaj.org/article/ed907d00b6e64e2c9854e9ccaadd97e6 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC5720814?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0006068 https://doaj.org/article/ed907d00b6e64e2c9854e9ccaadd97e6 PLoS Neglected Tropical Diseases, Vol 11, Iss 11, p e0006068 (2017) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2017 ftdoajarticles https://doi.org/10.1371/journal.pntd.0006068 2022-12-31T13:34:20Z In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability.This study compares the safety and efficacy of a freeze-dried trivalent antivenom (FDTAV) and the standard liquid AV provided by the Brazilian Ministry of Health (SLAV) to treat Bothrops, Lachesis and Crotalus snakebites. This was a prospective, randomized, open, phase IIb trial, carried out from June 2005 to May 2008 in the Brazilian Amazon. Primary efficacy endpoints were the suppression of clinical manifestations and return of hemostasis and renal function markers to normal ranges within the first 24 hours of follow-up. Primary safety endpoint was the presence of early adverse reactions (EAR) in the first 24 hours after treatment. FDTAV thermal stability was determined by estimating AV potency over one year at 56°C. Of the patients recruited, 65 and 51 were assigned to FDTAV and SLAV groups, respectively. Only mild EARs were reported, and they were not different between groups. There were no differences in fibrinogen (p = 0.911) and clotting time (p = 0.982) recovery between FDTAV and SLAV treated groups for Bothrops snakebites. For Lachesis and Crotalus snakebites, coagulation parameters and creatine phosphokinase presented normal values 24 hours after AV therapy for both antivenoms.Since promising results were observed for efficacy, safety and thermal stability, our results indicate that FDTAV is suitable for a larger phase III trial.ISRCTNregistry: ISRCTN12845255; DOI:10.1186/ISRCTN12845255 (http://www.isrctn.com/ISRCTN12845255). Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 11 11 e0006068 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Iran Mendonça-da-Silva Antônio Magela Tavares Jacqueline Sachett José Felipe Sardinha Lilian Zaparolli Maria Fátima Gomes Santos Marcus Lacerda Wuelton Marcelo Monteiro Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
In tropical areas, a major concern regarding snakebites treatment effectiveness relates to the failure in liquid antivenom (AV) distribution due to the lack of an adequate cold chain in remote areas. To minimize this problem, freeze-drying has been suggested to improve AV stability.This study compares the safety and efficacy of a freeze-dried trivalent antivenom (FDTAV) and the standard liquid AV provided by the Brazilian Ministry of Health (SLAV) to treat Bothrops, Lachesis and Crotalus snakebites. This was a prospective, randomized, open, phase IIb trial, carried out from June 2005 to May 2008 in the Brazilian Amazon. Primary efficacy endpoints were the suppression of clinical manifestations and return of hemostasis and renal function markers to normal ranges within the first 24 hours of follow-up. Primary safety endpoint was the presence of early adverse reactions (EAR) in the first 24 hours after treatment. FDTAV thermal stability was determined by estimating AV potency over one year at 56°C. Of the patients recruited, 65 and 51 were assigned to FDTAV and SLAV groups, respectively. Only mild EARs were reported, and they were not different between groups. There were no differences in fibrinogen (p = 0.911) and clotting time (p = 0.982) recovery between FDTAV and SLAV treated groups for Bothrops snakebites. For Lachesis and Crotalus snakebites, coagulation parameters and creatine phosphokinase presented normal values 24 hours after AV therapy for both antivenoms.Since promising results were observed for efficacy, safety and thermal stability, our results indicate that FDTAV is suitable for a larger phase III trial.ISRCTNregistry: ISRCTN12845255; DOI:10.1186/ISRCTN12845255 (http://www.isrctn.com/ISRCTN12845255). |
format |
Article in Journal/Newspaper |
author |
Iran Mendonça-da-Silva Antônio Magela Tavares Jacqueline Sachett José Felipe Sardinha Lilian Zaparolli Maria Fátima Gomes Santos Marcus Lacerda Wuelton Marcelo Monteiro |
author_facet |
Iran Mendonça-da-Silva Antônio Magela Tavares Jacqueline Sachett José Felipe Sardinha Lilian Zaparolli Maria Fátima Gomes Santos Marcus Lacerda Wuelton Marcelo Monteiro |
author_sort |
Iran Mendonça-da-Silva |
title |
Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. |
title_short |
Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. |
title_full |
Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. |
title_fullStr |
Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. |
title_full_unstemmed |
Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. |
title_sort |
safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the brazilian amazon: an open randomized controlled phase iib clinical trial. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2017 |
url |
https://doi.org/10.1371/journal.pntd.0006068 https://doaj.org/article/ed907d00b6e64e2c9854e9ccaadd97e6 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 11, Iss 11, p e0006068 (2017) |
op_relation |
http://europepmc.org/articles/PMC5720814?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0006068 https://doaj.org/article/ed907d00b6e64e2c9854e9ccaadd97e6 |
op_doi |
https://doi.org/10.1371/journal.pntd.0006068 |
container_title |
PLOS Neglected Tropical Diseases |
container_volume |
11 |
container_issue |
11 |
container_start_page |
e0006068 |
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1766344422008553472 |