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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Snake Bite

Intervention / Treatment
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* Drug: Bungarus multicinctus-candidus Antivenom
* Other: Supportive Care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control group<br>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<br>* Supportive Care only (endotracheal intubation, mechanical ventilation...)<br>|
| Active Comparator: antivenom group<br>The patients included during the third year (2006) were treated with antivenom therapy and supportive care. | Drug: Bungarus multicinctus-candidus Antivenom<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of mechanical ventilation |  | the length of ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical course during ICU stay |  | the 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 function |  | the length of ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antivenom, snake bite, Bungarus multicinctus, Vietnam