Trial | NCT00811239  Report issue

Official Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    81
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.
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.
Study Started
Mar 31
2004
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Dec 18
2008
Estimate

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.

Other Supportive Care

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

antivenom group Active Comparator

The patients included during the third year (2006) were treated with antivenom therapy and supportive care.

control group Other

As the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only.

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
No Results Posted