Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

This study is currently recruiting participants.
Verified May 2012 by Instituto Bioclon S.A. de C.V.
Sponsor:
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00639951
First received: March 13, 2008
Last updated: May 14, 2012
Last verified: May 2012

March 13, 2008
May 14, 2012
April 2008
October 2012   (final data collection date for primary outcome measure)
Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable [ Time Frame: 12 hours after initial treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639951 on ClinicalTrials.gov Archive Site
  • Evaluate the correlation between Dry Tube Test and Coagulation Test (PT, INR, PTT, platelets and fibrinogen) [ Time Frame: baseline, 2,4,6 hours and after each extra dose of Antivenom ] [ Designated as safety issue: No ]
  • Evaluate Venom and Antivenom Levels with the other parameters [ Time Frame: baseline, 2 hours after initial treatment and after each extra dose of Antivenom ] [ Designated as safety issue: Yes ]
  • Evaluate the possible relation of the serum markers (LDH, CPK, metalloproteinases)and local damage evolution. [ Time Frame: baseline, 2, 4,6 and after each extra dose of Antivenom ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation
Multicentric, Randomized,Controlled and Comparative Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

The purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose.

Evaluate the Utility of the the Dry Tube Test Evaluating its Correlation with Coagulation Test Results (fibrinogen, platelets, INR, PT and PTT).

Explore the Evolution of some Serum Markers (CK, DHL, metalloproteinase), Amount of Venom and Antivenom Levels and the Progression of Local Lesions.

Snake bite Envenomation is a Public Health Problem especially for tropical and subtropical countries. The WHO estimates 40 000 annual deaths in the world for this cause. In México the Ministry of Health estimated 3 882 cases on 2005, being the age of 15-44 the most affected. There are not official numbers of mortality, although the thought is that there are few cases of death, most of them related with a delay on treatment.

There are a broad variety of clinical presentations depending on many factors such as species, snake bite variability or patient conditions. Proteolytic action of venom produces amines and vasoactive peptides such as bradykinin, histamine and serotonin which cause capillary lesions with anticoagulant effects. Coagulopathy is one of the most important systemic consequences. The Dry Tube Test has been proposed as an indirect test to evaluate coagulopathy related to this pathology.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Snake Bite
  • Biological: Antivipmyn ®
    20 vials up front in a Single Dose of Antivipmyn
    Other Name: Crotalinae (pit viper) equine immune F(ab)2
  • Biological: Antivipmyn ®
    20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
    Other Name: Crotalinae (pit viper) equine immune F(ab)2
  • Experimental: A
    20 vials up front in a Single Dose of Antivipmyn
    Intervention: Biological: Antivipmyn ®
  • Experimental: B
    20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
    Intervention: Biological: Antivipmyn ®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
July 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men and women 6 to 65 years of age
  • Presenting for emergency treatment of snake bite
  • Requiring treatment with antivenom
  • Informed consent document read and signed by patient (or parent/legal guardian)
  • Participation within the last month on any clinical trial
  • Arrival to Hospital within 24 hours after the snake bite

Exclusion Criteria:

  • Allergy to horse serum
  • Underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin K deficiency, hepatic disease)
  • Use of AINE 48 hours previously
  • Use of any antivenom 2 weeks previously
  • Pregnancy or breast-feeding women
Both
6 Years to 65 Years
No
Contact: Walter Garcia Ubbelohde, MD 54883700 ext 3785 wgarcia@silanes.com.mx
Contact: Anabel Loza, MD 54883700 ext 3823 aloza@silanes.com.mx
Mexico
 
NCT00639951
YA-07/01
No
Instituto Bioclon S.A. de C.V.
Instituto Bioclon S.A. de C.V.
Not Provided
Study Director: Walter García, MD Instituto Bioclon
Study Chair: Anabel Loza, MD Instituto Bioclon
Instituto Bioclon S.A. de C.V.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP