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Completed

NCT Number: NCT00811239

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vietnam Poison Control Center, Bach Mai Hospital, HMU

Hanoi, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bungarus multicinctus-candidus Antivenom

Drug

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.

Supportive Care

Other

Supportive Care only (endotracheal intubation, mechanical ventilation...)

Primary outcomes

  1. duration of mechanical ventilation

    Time frame: the length of ICU stay

Secondary outcomes

  1. clinical course during ICU stay

    Time frame: the length of ICU stay

  2. complications (Ventilator associated pneumonia...)

    Time frame: the length of ICU stay

  3. adverse effects (anaphylaxis, serum sickness...)

    Time frame: the length of ICU stay

  4. hyponatremia, renal and liver function

    Time frame: the length of ICU stay

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Collaborators

  • Karolinska Institutet
  • Swedish International Development Cooperation Agency (SIDA)

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 18, 2008
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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