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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Instituto Bioclon S.A. de C.V..
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention Phase
Snake Bite
Biological: Antivipmyn ®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicentric, Randomized,Controlled and Comparative Study to Evaluate the Efficacy of Two Treatment Schemes With Antivipmyn ® for the Treatment of Snake Bite Envenomation

Further study details as provided by Instituto Bioclon S.A. de C.V.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: April 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
20 vials up front in a Single Dose of Antivipmyn
Biological: Antivipmyn ®
20 vials up front in a Single Dose of Antivipmyn
Other Name: Crotalinae (pit viper) equine immune F(ab)2
Experimental: B
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
Biological: Antivipmyn ®
20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®
Other Name: Crotalinae (pit viper) equine immune F(ab)2

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639951

Contacts
Contact: Walter Garcia Ubbelohde, MD 54883700 ext 3785 wgarcia@silanes.com.mx
Contact: Anabel Loza, MD 54883700 ext 3823 aloza@silanes.com.mx

Locations
Mexico
Hermosillo Site Recruiting
Sonora, Hermosillo, Mexico
Nayarit Site Suspended
Tepic, Nayarit, Mexico, 63000
Hospital Universitario de la UANL "Dr. José Eleuterio González" Recruiting
Monterrey, NL, Mexico, 64460
Ciudad Valles Site Recruiting
Ciudad Valles, San Luis Potosi, Mexico
Tampico Site Withdrawn
Tampico, Tamaulipas, Mexico, 89130
Tempoal Site Suspended
Tempoal, Veracruz, Mexico, 92061
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
Investigators
Study Director: Walter García, MD Instituto Bioclon
Study Chair: Anabel Loza, MD Instituto Bioclon
  More Information

No publications provided

Responsible Party: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00639951     History of Changes
Other Study ID Numbers: YA-07/01
Study First Received: March 13, 2008
Last Updated: May 14, 2012
Health Authority: Mexico: Ministry of Health
Mexico: Federal Commission for Sanitary Risks Protection

Keywords provided by Instituto Bioclon S.A. de C.V.:
Snake Bite
Antivenin Treatment

Additional relevant MeSH terms:
Snake Bites
Bites and Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries

ClinicalTrials.gov processed this record on September 14, 2014