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

NCT00811239 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2008-12-18

No results posted yet for this study

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.

Conditions

  • Snake Bite

Interventions

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...)

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Swedish International Development Cooperation Agency (SIDA)

    collaborator OTHER_GOV

  • Hanoi Medical University

    lead OTHER

Principal Investigators

  • Jonas Höjer, MD, PhD · Karorinska Institute, Swedish Poisons Information Centre

Study Design

Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Vietnam

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811239 on ClinicalTrials.gov