Clinical trial evaluating the safety, neutralizing capacity and the lowest effective dose for antivenom treatment of multiple Africanized bees stings Apis mellifera

Clinical trial phase I/II to evaluate the safety, the neutralizing capacity and the lowest effective dose of antivenom for the treatment of multiple africanized honey bees stings Apis mellifera- APIS Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-3fthf8

Enrollment

Unknown

Registered

2020-07-26

Start date

2015-04-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stings, insect Bites

Interventions

The only study group is the intervention group, which consisted of 20 participants who received antiapillic serum, once, diluted in 250 mL 0.9% sodium chloride, by intravenous infusion in 2 hours, acc

Biological/vaccine

A12.207.152.846.500

Eligibility

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Be aged over 18 and under 60 years of both sexes; having a diagnosis of crash with bees Apis; have the consent of the patient or family to receive antivenom.

Exclusion criteria

Exclusion criteria: Have had frequent contact with products of horse; have had previous adverse reaction to receiving the antivenom; to be pregnant; be with chronic disease, including congenital and acquired immunodeficiencies; introduce diseases that the combined use contraindication antihistamines, corticosteroids and potent analgesics, including allergic reaction.

Design outcomes

Primary

Measure	Time frame
Mild, moderate or severe acute adverse events attributable to the intervention.;Late adverse events attributable to the intervention.;As for primary outcomes, the majority of episodes were characterized as mild. There was only one episode classified as moderate characterized by erythroderma and itchy skin. There were no serious adverse events. All participants completed the intravenous infusion of AAV in two hours and there was no loss of follow-up after discharged.	—

Measure

Time frame

Mild, moderate or severe acute adverse events attributable to the intervention.;Late adverse events attributable to the intervention.;As for primary outcomes, the majority of episodes were characterized as mild. There was only one episode classified as moderate characterized by erythroderma and itchy skin. There were no serious adverse events. All participants completed the intravenous infusion of AAV in two hours and there was no loss of follow-up after discharged.

—

Secondary

Measure	Time frame
Most effective dose of antivenom to neutralize the amount of venom inoculated.;Regarding the preliminary assessment of efficacy, there was a significant clinical improvement in the symptoms after AAV administration, characterized by a reduction in the classification of the clinical severity score and a marked improvement in patients classified as severe.	—

Countries

Brazil

Contacts

Public ContactAlexandre;Benedito Barbosa;Barraviera

Faculdade de Medicina de Botucatu;Faculdade de Medicina de Botucatu

barbosa.an@ymail.com;benedito.barraviera@unesp.br+55(14)38801282;1438807108

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 15, 2026