NCT00811239

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
Last Updated

December 18, 2008

Status Verified

December 1, 2008

Enrollment Period

2.8 years

First QC Date

December 16, 2008

Last Update Submit

December 17, 2008

Conditions

Snake Bite

Keywords

antivenomsnake biteBungarus multicinctusVietnam

Outcome Measures

Primary Outcomes (1)

  • duration of mechanical ventilation

    the length of ICU stay

Secondary Outcomes (4)

  • clinical course during ICU stay

    the length of ICU stay

  • complications (Ventilator associated pneumonia...)

    the length of ICU stay

  • adverse effects (anaphylaxis, serum sickness...)

    the length of ICU stay

  • hyponatremia, renal and liver function

    the length of ICU stay

Study Arms (2)

control group

OTHER

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

antivenom group

ACTIVE COMPARATOR

The patients included during the third year (2006) were treated with antivenom therapy and supportive care.

Drug: Bungarus multicinctus-candidus Antivenom

Interventions

Bungarus multicinctus-candidus AntivenomDRUG

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.

antivenom group
Supportive CareOTHER

Supportive Care only (endotracheal intubation, mechanical ventilation...)

control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Envenomed by B. multicinctus
  • Showed clinical signs of systemic envenomation (neuromuscular signs)
  • Provided written informed consent (during the year 2006)

You may not qualify if:

  • Pregnancy
  • Patients had a known history of intolerance to equine serum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vietnam Poison Control Center, Bach Mai Hospital, HMU

Hanoi, Vietnam

Location

Related Publications (7)

  • 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.

    PMID: 8544231RESULT

  • 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.

    PMID: 9509180RESULT

  • 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.

    PMID: 11837876RESULT

  • 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.

    PMID: 11174237RESULT

  • White J. Envenoming and antivenom use in Australia. Toxicon. 1998 Nov;36(11):1483-92. doi: 10.1016/s0041-0101(98)00138-x.

    PMID: 9792162RESULT

  • 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.

    PMID: 9042094RESULT

  • 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.

    PMID: 20358414DERIVED

MeSH Terms

Conditions

Snake Bites

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jonas Höjer, MD, PhD

    Karorinska Institute, Swedish Poisons Information Centre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 18, 2008

Study Start

March 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

December 18, 2008

Record last verified: 2008-12

Locations

VN(1)