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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00811239
Enrollment
81
Registered
2008-12-18
Start date
2004-03-31
Completion date
2006-12-31
Last updated
2008-12-18

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

Conditions

Snake Bite

Keywords

antivenom, snake bite, Bungarus multicinctus, Vietnam

Brief summary

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.

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.

Interventions

DRUGBungarus 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.

OTHERSupportive Care

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

Sponsors

Karolinska Institutet
CollaboratorOTHER
Swedish International Development Cooperation Agency (SIDA)
CollaboratorOTHER_GOV
Hanoi Medical University
Lead SponsorOTHER

Study design

Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
duration of mechanical ventilationthe length of ICU stay

Secondary

MeasureTime frame
clinical course during ICU staythe length of ICU stay
complications (Ventilator associated pneumonia...)the length of ICU stay
adverse effects (anaphylaxis, serum sickness...)the length of ICU stay
hyponatremia, renal and liver functionthe length of ICU stay

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026