Freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: A study about safety and efficacy

Phase 2

Completed

• Conditions: Snakebites; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN12845255
• Lead Sponsor: Army Institute of Biology

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29176824 Results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2008-12-15
• Study Start: 2017-07-07
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Male and female subjects
2. Aged between 12 and 70 years old
3. Bothrops, Lachesis and Crotalus snakebites are diagnosed using clinical, epidemiological and laboratorial evaluation

Exclusion Criteria

1. Pregnancy or breastfeeding
2. Previous hematological disorders
3. Known immunodeficiencies (HIV, malignancies, chemotherapy or other immunosuppressive treatments)
4. Previous treatment with snake AVs and history of any moderate/severe allergic reaction in the past
5. Presenting with severe snake envenomings, defined for Bothrops and Lachesis as life-threatening snakebites with severe bleeding, hypotension, shock and acute renal failure, and for Crotalus as intense rhabdomyolisis and severe acute renal failure were not included

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early adverse reactions of AV therapy is measured using the clinical examinations for urticaria, asthma-like crisis, laryngeal edema and shock in the first 24 hours after treatment.

Secondary Outcome Measures

Name	Time	Method
Presence of late adverse events are measured using clinical examinations (fever, urticarial, arthralgia, adenomegaly, neurological and renal complications at 24 hours until 15 days after treatment.