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

Phase 1

Completed

• Conditions: Snake Bite
• Interventions: Other: Supportive Care; Drug: Bungarus multicinctus-candidus Antivenom

• Registration Number: NCT00811239
• Lead Sponsor: Hanoi Medical University

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.

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-12
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-17
• Last Update Submitted: 2008-12-17
• Study First Posted: 2008-12-18
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Supportive Care	As the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only.
antivenom group	Bungarus multicinctus-candidus Antivenom	The patients included during the third year (2006) were treated with antivenom therapy and supportive care.

Primary Outcome Measures

Name	Time	Method
duration of mechanical ventilation	the length of ICU stay

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vietnam Poison Control Center, Bach Mai Hospital, HMU; 🇻🇳 Hanoi, Vietnam