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A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus

This study has been completed.
Sponsor:
Collaborators:
Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)
Information provided by:
Hanoi Medical University
ClinicalTrials.gov Identifier:
NCT00811239
First received: December 16, 2008
Last updated: December 17, 2008
Last verified: December 2008
  Purpose

In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus. Hitherto, these victims have received supportive care only. The aims of this study were to assess the possible efficacy and side effects of a newly produced antivenom.


Condition Intervention Phase
Snake Bite
Drug: Bungarus multicinctus-candidus Antivenom
Other: Supportive Care
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus

Further study details as provided by Hanoi Medical University:

Primary Outcome Measures:
  • duration of mechanical ventilation [ Time Frame: the length of ICU stay ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • clinical course during ICU stay [ Time Frame: the length of ICU stay ] [ Designated as safety issue: Yes ]
  • complications (Ventilator associated pneumonia...) [ Time Frame: the length of ICU stay ] [ Designated as safety issue: Yes ]
  • adverse effects (anaphylaxis, serum sickness...) [ Time Frame: the length of ICU stay ] [ Designated as safety issue: Yes ]
  • hyponatremia, renal and liver function [ Time Frame: the length of ICU stay ] [ Designated as safety issue: Yes ]

Enrollment: 81
Study Start Date: March 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control group
As the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only.
Other: Supportive Care
Supportive Care only (endotracheal intubation, mechanical ventilation...)
Active Comparator: antivenom group
The patients included during the third year (2006) were treated with antivenom therapy and supportive care.
Drug: Bungarus multicinctus-candidus Antivenom
Five to ten ampoules of antivenom, depending on severity of muscle paralysis, were diluted with isotonic glucose solution to have total 50 ml and infused intravenously by electric pump during one hour. After a period of 6-8 hours, a second infusion was administered, under similar condition to the first, if no clinical improvement or adverse reaction had been noted. The patients also received supportive care such as intubation, ventilation...if necessary.

Detailed Description:

Venomous snakebites constitute a serious health problem in many Asian countries. In Vietnam, the burden of snakebite on the public health stimulated Calmette to conduct original studies at the Vaccine Institute in Saigon over a hundred years ago and to develop the first snake antivenom ever.

In northern Vietnam, a vast majority of the most severe envenomed patients are bitten by Bungarus multicinctus, which is the only krait species giving rise to significant morbidity and mortality in the area. Its venom contains toxins which can cause severe neuromuscular blockade but which do not give rise to swelling or necrosis at the site of the bite.

Supportive care is an important part of the management of snakebites, but antivenom administration is the mainstay therapy in the majority of medically significant envenomings. Such specific therapy may dramatically reduce the consequences of the envenomation. In Vietnam, no specific antivenom against B. multicinctus has been available until recently when it has produced for clinical use.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Envenomed by B. multicinctus
  • Showed clinical signs of systemic envenomation (neuromuscular signs)
  • Provided written informed consent (during the year 2006)

Exclusion Criteria:

  • Pregnancy
  • Patients had a known history of intolerance to equine serum
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811239

Locations
Vietnam
Vietnam Poison Control Center, Bach Mai Hospital, HMU
Hanoi, Vietnam
Sponsors and Collaborators
Hanoi Medical University
Karolinska Institutet
Swedish International Development Cooperation Agency (SIDA)
Investigators
Study Director: Jonas Höjer, MD, PhD Karorinska Institute, Swedish Poisons Information Centre
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00811239     History of Changes
Other Study ID Numbers: antivenom, second study on snakebite
Study First Received: December 16, 2008
Last Updated: December 17, 2008
Health Authority: Vietnam: Ministry of Health

Keywords provided by Hanoi Medical University:
antivenom
snake bite
Bungarus multicinctus
Vietnam

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Chemically-Induced Disorders
Poisoning
Wounds and Injuries
Antivenins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014