A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus
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|ClinicalTrials.gov Identifier: NCT00811239|
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
|Condition or disease||Intervention/treatment||Phase|
|Snake Bite||Drug: Bungarus multicinctus-candidus Antivenom Other: Supportive Care||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Controlled Clinical Trial on The Use of a Specific Antivenom Against Envenoming by Bungarus Multicinctus|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
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
Supportive Care only (endotracheal intubation, mechanical ventilation...)
Active Comparator: antivenom group
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811239
|Vietnam Poison Control Center, Bach Mai Hospital, HMU|
|Study Director:||Jonas Höjer, MD, PhD||Karorinska Institute, Swedish Poisons Information Centre|