A Phase 1/2 interventional study of Bungarus multicinctus-candidus Antivenom and Supportive Care in Snake Bite, sponsored by Hanoi Medical University. Completed at 1 site in Vietnam. Per ClinicalTrials.gov, last updated 2008-12-18.
Sponsored by Hanoi Medical University · Phase 1/2, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.
This study's enrollment of 81 is above the median of 70 across 18 interventional studies indexed under Snake Bites.
Browse Snake Bites studies →Hanoi Medical University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The patients included during the third year (2006) were treated with antivenom therapy and supportive care.
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.
Supportive Care only (endotracheal intubation, mechanical ventilation...)
duration of mechanical ventilation
Time frame: the length of ICU stay
clinical course during ICU stay
Time frame: the length of ICU stay
complications (Ventilator associated pneumonia...)
Time frame: the length of ICU stay
adverse effects (anaphylaxis, serum sickness...)
Time frame: the length of ICU stay
hyponatremia, renal and liver function
Time frame: the length of ICU stay
The record gives a start of Mar 2004, a primary completion of Dec 2006 and a completion of Dec 2006. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Hanoi Medical University