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

Snake Bite Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811239
• Other study ID #: antivenom
• Secondary ID: second study on
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 16, 2008
• Last updated: December 17, 2008
• Start date: March 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2008
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Snake Bite
• Snake Bites

Intervention

Drug:
• Bungarus 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.

Other:
• Supportive Care
Supportive Care only (endotracheal intubation, mechanical ventilation...)

Locations

Country	Name	City	State
Vietnam	Vietnam Poison Control Center, Bach Mai Hospital, HMU	Hanoi

Sponsors (3)

Lead Sponsor	Collaborator
Hanoi Medical University	Karolinska Institutet, Swedish International Development Cooperation Agency (SIDA)

Country where clinical trial is conducted

Vietnam, 

References & Publications (6)

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. — View 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. — View Citation

Dart RC, McNally J. Efficacy, safety, and use of snake antivenoms in the United States. Ann Emerg Med. 2001 Feb;37(2):181-8. Review. — View Citation

Karlson-Stiber C, Persson H, Heath A, Smith D, al-Abdulla IH, Sjöström 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. — View 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. — View Citation

White J. Envenoming and antivenom use in Australia. Toxicon. 1998 Nov;36(11):1483-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of mechanical ventilation		the length of ICU stay	Yes
Secondary	clinical course during ICU stay		the length of ICU stay	Yes
Secondary	complications (Ventilator associated pneumonia...)		the length of ICU stay	Yes
Secondary	adverse effects (anaphylaxis, serum sickness...)		the length of ICU stay	Yes
Secondary	hyponatremia, renal and liver function		the length of ICU stay	Yes