A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom
Abstract Background Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality o...
Published in: | Journal of Venomous Animals and Toxins including Tropical Diseases |
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ftdoajarticles:oai:doaj.org/article:745e7754736940009414bc0c1325299e 2023-05-15T15:18:20+02:00 A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom Alexandre Naime Barbosa Leslie Boyer Jean-Philippe Chippaux Natalia Bronzatto Medolago Carlos Antonio Caramori Ariane Gomes Paixão João Paulo Vasconcelos Poli Mônica Bannwart Mendes Lucilene Delazari dos Santos Rui Seabra Ferreira Jr Benedito Barraviera 2017-04-01T00:00:00Z https://doi.org/10.1186/s40409-017-0106-y https://doaj.org/article/745e7754736940009414bc0c1325299e EN eng SciELO http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1678-91992017000100309&lng=en&tlng=en https://doaj.org/toc/1678-9199 1678-9199 doi:10.1186/s40409-017-0106-y https://doaj.org/article/745e7754736940009414bc0c1325299e Journal of Venomous Animals and Toxins including Tropical Diseases, Vol 23, Iss 0 (2017) Apis mellifera Bee venom Toxins Envenomation Heterologous serum Apilic antivenom Bee antivenom Arctic medicine. Tropical medicine RC955-962 Toxicology. Poisons RA1190-1270 Zoology QL1-991 article 2017 ftdoajarticles https://doi.org/10.1186/s40409-017-0106-y 2022-12-31T08:37:59Z Abstract Background Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A2, cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. Methods In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. Results This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research – CONEP) and sanitation (National Health Surveillance Agency – ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. Conclusions This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera. The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Journal of Venomous Animals and Toxins including Tropical Diseases 23 1 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Apis mellifera Bee venom Toxins Envenomation Heterologous serum Apilic antivenom Bee antivenom Arctic medicine. Tropical medicine RC955-962 Toxicology. Poisons RA1190-1270 Zoology QL1-991 |
spellingShingle |
Apis mellifera Bee venom Toxins Envenomation Heterologous serum Apilic antivenom Bee antivenom Arctic medicine. Tropical medicine RC955-962 Toxicology. Poisons RA1190-1270 Zoology QL1-991 Alexandre Naime Barbosa Leslie Boyer Jean-Philippe Chippaux Natalia Bronzatto Medolago Carlos Antonio Caramori Ariane Gomes Paixão João Paulo Vasconcelos Poli Mônica Bannwart Mendes Lucilene Delazari dos Santos Rui Seabra Ferreira Jr Benedito Barraviera A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom |
topic_facet |
Apis mellifera Bee venom Toxins Envenomation Heterologous serum Apilic antivenom Bee antivenom Arctic medicine. Tropical medicine RC955-962 Toxicology. Poisons RA1190-1270 Zoology QL1-991 |
description |
Abstract Background Envenomation caused by multiple stings from Africanized honeybees Apis mellifera constitutes a public health problem in the Americas. In 2015, the Brazilian Ministry of Health reported 13,597 accidents (incidence of seven cases per 100,000 inhabitants) with 39 deaths (lethality of 0.25%). The toxins present in the venom, which include melittin and phospholipase A2, cause lesions in diverse organs and systems that may be fatal. As there has been no specific treatment to date, management has been symptomatic and supportive only. Methods In order to evaluate the safety and neutralizing capacity of a new apilic antivenom, as well as to confirm its lowest effective dose, a clinical protocol was developed to be applied in a multicenter, non-randomized and open phase I/II clinical trial. Twenty participants with more than five stings, aged more than 18 years, of both sexes, who have not previously received the heterologous serum against bee stings, will be included for 24 months. The proposed dose was based on the antivenom neutralizing capacity and the number of stings. Treatment will be administered only in a hospital environment and the participants will be evaluated for a period up to 30 days after discharge for clinical and laboratory follow-up. Results This protocol, approved by the Brazilian regulatory agencies for ethics (National Commission for Ethics on Research – CONEP) and sanitation (National Health Surveillance Agency – ANVISA), is a guideline constituted by specific, adjuvant, symptomatic and complementary treatments, in addition to basic orientations for conducting a clinical trial involving heterologous sera. Conclusions This is the first clinical trial protocol designed specifically to evaluate the preliminary efficacy and safety of a new antivenom against stings from the Africanized honeybee Apis mellifera. The results will support future studies to confirm a new treatment for massive bee attack that has a large impact on public health in the Americas. |
format |
Article in Journal/Newspaper |
author |
Alexandre Naime Barbosa Leslie Boyer Jean-Philippe Chippaux Natalia Bronzatto Medolago Carlos Antonio Caramori Ariane Gomes Paixão João Paulo Vasconcelos Poli Mônica Bannwart Mendes Lucilene Delazari dos Santos Rui Seabra Ferreira Jr Benedito Barraviera |
author_facet |
Alexandre Naime Barbosa Leslie Boyer Jean-Philippe Chippaux Natalia Bronzatto Medolago Carlos Antonio Caramori Ariane Gomes Paixão João Paulo Vasconcelos Poli Mônica Bannwart Mendes Lucilene Delazari dos Santos Rui Seabra Ferreira Jr Benedito Barraviera |
author_sort |
Alexandre Naime Barbosa |
title |
A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom |
title_short |
A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom |
title_full |
A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom |
title_fullStr |
A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom |
title_full_unstemmed |
A clinical trial protocol to treat massive Africanized honeybee (Apis mellifera) attack with a new apilic antivenom |
title_sort |
clinical trial protocol to treat massive africanized honeybee (apis mellifera) attack with a new apilic antivenom |
publisher |
SciELO |
publishDate |
2017 |
url |
https://doi.org/10.1186/s40409-017-0106-y https://doaj.org/article/745e7754736940009414bc0c1325299e |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Journal of Venomous Animals and Toxins including Tropical Diseases, Vol 23, Iss 0 (2017) |
op_relation |
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1678-91992017000100309&lng=en&tlng=en https://doaj.org/toc/1678-9199 1678-9199 doi:10.1186/s40409-017-0106-y https://doaj.org/article/745e7754736940009414bc0c1325299e |
op_doi |
https://doi.org/10.1186/s40409-017-0106-y |
container_title |
Journal of Venomous Animals and Toxins including Tropical Diseases |
container_volume |
23 |
container_issue |
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