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

Hanoi Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Snake Bite

Treatments: Drug: Bungarus multicinctus-candidus Antivenom; Other: Supportive Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00811239

second study on snakebite

antivenom

Details and patient eligibility

About

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.

Full 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.

Enrollment: 81 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

control group

Other group

Description:

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

Treatment:

Other: Supportive Care

antivenom group

Active Comparator group

Description:

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

Treatment:

Drug: Bungarus multicinctus-candidus Antivenom