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

NCT00639951 | Terminated Phase 4

• 1 other identifier: YA-07/01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Snake Bite

Keywords

Snake Bite; Antivenin Treatment

Outcome Measures

Primary Outcomes (1)

• Resolution of systemic signs and symptoms of snake bite envenomation expressed as % of patients requiring additional antivenom and % of patients that are stable

  12 hours after initial treatment

Secondary Outcomes (3)

• Evaluate the correlation between Dry Tube Test and Coagulation Test (PT, INR, PTT, platelets and fibrinogen)

  baseline, 2,4,6 hours and after each extra dose of Antivenom

• Evaluate Venom and Antivenom Levels with the other parameters

  baseline, 2 hours after initial treatment and after each extra dose of Antivenom

• Evaluate the possible relation of the serum markers (LDH, CPK, metalloproteinases)and local damage evolution.

  baseline, 2, 4,6 and after each extra dose of Antivenom

Study Arms (2)

A Normal dose Group

ACTIVE COMPARATOR

20 vials up front in a Single Dose of Antivipmyn in 500 ml of solution IV, administered in 60 minutes. After 12 hours, it has to be perfomed a clinical evaluation of the patient. Each patient is going to have clinical studies of coagulation time and also the fibrinogen measures, this at 2, 4, 6, 8, 10, 12, 48, 72, 96 hours.All patients who have received at least one dose of medication study will be contacted by telephone to investigate the presence of symptoms suggestive of continuing with effect snake venom, or the presence of an adverse event, or any signs or symptoms indicating the presence of a hypersensitivity response to Antivipmyn® including serum sickness. If symptoms suggestive of an adverse event were discovered, the patient will referred for appropriate treatment.

Biological: A

B Placebo Group

PLACEBO COMPARATOR

20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®. The treatment schedule for each subject is a dose of 5 vials Antivipmyn® every 2 hours to complete 20 vials, the total duration is 6 hours of the treatment. Each dose IV shall apply in physiological solution 250ml, and finish its application in 15 minutes. For pediatric patients the volume administered should not exceed the recommended fluid volume according to your body weight. After the assessment at 12 hours, it can be administered at the discretion of more antivenom attending by the physician.

Biological: Antivipmyn ®

Interventions

A BIOLOGICAL

20 vials up front in a Single Dose of Antivipmyn

Also known as: Crotalinae (pit viper) equine immune F(ab)2

A Normal dose Group

Antivipmyn ® BIOLOGICAL

20 vials fractionated into 4 doses of 5 vials each of Antivipmyn ®

Also known as: Crotalinae (pit viper) equine immune F(ab)2

B Placebo Group

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Bioclon S.A. de C.V.: lead

Study Sites (5)

Hermosillo Site

Sonora, Hermosillo, Mexico

Location

Nayarit Site

Tepic, Nayarit, 63000, Mexico

Location

Hospital Universitario de la UANL "Dr. José Eleuterio González"

Monterrey, Nuevo León, 64460, Mexico

Location

Ciudad Valles Site

Ciudad Valles, San Luis Potosí, Mexico

Location

Tempoal Site

Tempoal de Sánchez, Veracruz, 92061, Mexico

Location

MeSH Terms

Conditions

Snake Bites

Interventions

antivipmyn Africa

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Walter García, MD

  Instituto Bioclon

  STUDY DIRECTOR

• Anabel Loza, MD

  Instituto Bioclon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2008
• First Posted: March 20, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 20, 2016

Record last verified: 2016-07

Locations

ME (5)