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

Safety and efficacy of freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12845255
Enrollment
116
Registered
2017-07-07
Start date
2005-06-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Snakebites Injury, Occupational Diseases, Poisoning Snakebites

Interventions

After snakebite envenoming diagnosis, participants are randomly assigned to one of two arms with allocation ratio 1:1. The randomisation list is computer-generated. When a patient is considered to mee

Sponsors

Army Institute of Biology
Lead Sponsor
Tropical Medicine Foundation Dr. Heitor Vieira Dourado
Collaborator
Instituto de Biologia do Exército
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026