A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus
NCT ID: NCT00811239
Last Updated: 2008-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
81 participants
INTERVENTIONAL
2004-03-31
2006-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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control group
As the antivenom was not yet clinically available until 2006, all patients included during the first two years (2004-2005) received supportive therapy only.
Supportive Care
Supportive Care only (endotracheal intubation, mechanical ventilation...)
antivenom group
The patients included during the third year (2006) were treated with antivenom therapy and supportive care.
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.
Interventions
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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.
Supportive Care
Supportive Care only (endotracheal intubation, mechanical ventilation...)
Eligibility Criteria
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Inclusion Criteria
* Showed clinical signs of systemic envenomation (neuromuscular signs)
* Provided written informed consent (during the year 2006)
Exclusion Criteria
* Patients had a known history of intolerance to equine serum
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Swedish International Development Cooperation Agency (SIDA)
OTHER_GOV
Hanoi Medical University
OTHER
Principal Investigators
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Jonas Höjer, MD, PhD
Role: STUDY_DIRECTOR
Karorinska Institute, Swedish Poisons Information Centre
Locations
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Vietnam Poison Control Center, Bach Mai Hospital, HMU
Hanoi, , Vietnam
Countries
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References
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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.
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.
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.
Dart RC, McNally J. Efficacy, safety, and use of snake antivenoms in the United States. Ann Emerg Med. 2001 Feb;37(2):181-8. doi: 10.1067/mem.2001.113372.
White J. Envenoming and antivenom use in Australia. Toxicon. 1998 Nov;36(11):1483-92. doi: 10.1016/s0041-0101(98)00138-x.
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.
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.
Other Identifiers
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second study on snakebite
Identifier Type: -
Identifier Source: secondary_id
antivenom
Identifier Type: -
Identifier Source: org_study_id