ArticleThe journal of venomous animals and toxins including tropical diseases2017
A clinical trial protocol to treat massive Africanized honeybee (
Article in The journal of venomous animals and toxins including tropical diseases, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed.
- Single-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom.Frontiers in immunology · 2021Trial
- Epidemiology and management of wildlife contacts in an emergency department of French Guiana.PLoS neglected tropical diseases · 2025Observational
- Diagnosis of human envenoming by terrestrial venomous animals: Routine, advances, and perspectives.Toxicon: X · 2024Article
- Clinical complications in envenoming byFrontiers in immunology · 2024Review
- Challenges and Opportunities in Clinical Diagnostic Routine of Envenomation Using Blood Plasma Proteomics.Toxins · 2023Review
- Launching a CDMO in Brazil aiming to develop biopharmaceuticals for clinical trials.The journal of venomous animals and toxins including tropical diseases · 2022Article
- Article
- Neuroactive venom compounds obtained fromThe journal of venomous animals and toxins including tropical diseases · 2021Article
- Energetic supplementation for maintenance or development ofThe journal of venomous animals and toxins including tropical diseases · 2020Article
- Bee sting envenomation severe cases in Manaus, Brazilian Amazon: clinical characteristics and immune markers of case reports.Revista da Sociedade Brasileira de Medicina Tropical · 2020Article
- Bee Updated: Current Knowledge on Bee Venom and Bee Envenoming Therapy.Frontiers in immunology · 2019Review
- Divergences between the Brazilian national information systems for recording deaths from venomous animals.The journal of venomous animals and toxins including tropical diseases · 2019Article
- Quality of horse F(ab')The journal of venomous animals and toxins including tropical diseases · 2018Article
- Antivenom therapy: efficacy of premedication for the prevention of adverse reactions.The journal of venomous animals and toxins including tropical diseases · 2018Review
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEnvenomation caused by multiple stings from Africanized honeybees
methodsIn 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.
resultsThis 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.
conclusionsThis 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
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