Clinical trial NCT00811239: A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus
Official title: A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Snake Bite
Keywords: antivenom
snake bite
Bungarus multicinctus
Vietnam
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2008-12-18
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: duration of mechanical ventilation
timeFrame: the length of ICU stay
Secondary outcomes:
measure: clinical course during ICU stay
timeFrame: the length of ICU stay
measure: complications (Ventilator associated pneumonia...)
timeFrame: the length of ICU stay
measure: adverse effects (anaphylaxis, serum sickness...)
timeFrame: the length of ICU stay
measure: hyponatremia, renal and liver function
timeFrame: the length of ICU stay
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam Poison Control Center, Bach Mai Hospital, HMU
Study officials:
affiliation: Karorinska Institute, Swedish Poisons Information Centre
name: Jonas Höjer, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Chan JC, Cockram CS, Buckley T, Young K, Kay R, Tomlinson B. Evenoming by Bungarus multicinctus (many-banded krait) in Hong Kong. J Trop Med Hyg. 1995 Dec;98(6):457-60.
citation: Pe T, Myint T, Htut A, Htut T, Myint AA, Aung NN. Envenoming by Chinese krait (Bungarus multicinctus) and banded krait (B. fasciatus) in Myanmar. Trans R Soc Trop Med Hyg. 1997 Nov-Dec;91(6):686-8. doi: 10.1016/s0035-9203(97)90524-1.
citation: Cheng AC, Winkel KD. Snakebite and antivenoms in the Asia-Pacific: wokabaut wantaim, raka hebou ("walking together"). Med J Aust. 2001 Dec 3-17;175(11-12):648-51. doi: 10.5694/j.1326-5377.2001.tb143762.x. No abstract available.
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citation: White J. Envenoming and antivenom use in Australia. Toxicon. 1998 Nov;36(11):1483-92. doi: 10.1016/s0041-0101(98)00138-x.
citation: Karlson-Stiber C, Persson H, Heath A, Smith D, al-Abdulla IH, Sjostrom L. First clinical experiences with specific sheep Fab fragments in snake bite. Report of a multicentre study of Vipera berus envenoming. J Intern Med. 1997 Jan;241(1):53-8. doi: 10.1046/j.1365-2796.1997.80896000.x.
citation: Ha TH, Hojer J, Trinh XK, Nguyen TD. A controlled clinical trial of a novel antivenom in patients envenomed by Bungarus multicinctus. J Med Toxicol. 2010 Dec;6(4):393-7. doi: 10.1007/s13181-010-0051-4.