Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation

This study has been completed.
Sponsor:
Collaborator:
University of Arizona
Information provided by:
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00624078
First received: December 26, 2007
Last updated: February 19, 2011
Last verified: February 2011
  Purpose

This treatment protocol will enable therapeutic use of Anascorp in the management of systemic manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise be unavailable. The working hypotheses are as follows:

  1. The investigational antivenom is safe as treatment of scorpion sting envenomation.
  2. The investigational antivenom is effective as treatment of scorpion sting envenomation.

Condition Intervention Phase
Scorpion Sting Envenomation
Drug: Antivenin Centruroides (scorpion) F(ab)2 Anascorp™
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation

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

Primary Outcome Measures:
  • Evaluate the adverse events profile of each patient [ Time Frame: immediately after treatment, 24 hrs and 14 days. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Resolution of systemic signs of scorpion envenomation [ Time Frame: after treatment ] [ Designated as safety issue: No ]

Enrollment: 1426
Study Start Date: May 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients who arrive to emergency room with scorpion sting envenomation will be evaluated according to inclusion/exclusion criteria. After informed consent has been signed they will be assigned to unique treatment arm with Anascorp.
Drug: Antivenin Centruroides (scorpion) F(ab)2 Anascorp™
three vials diluted in 20 to 50 mL normal saline administered intravenously. Subsequent single vial doses of Anascorp, up to a total of five vials administered at thirty minutes intervals until resolution of symptoms.

Detailed Description:

The purpose of this Open Label, Multi-Center Treatment Protocol, phase III trial is to examine the safety and efficacy of Anascorp, for treatment of patients envenomed by scorpion sting.

The treatment protocol, including up to 25 Arizona sites, increases the total number of subjects receiving Anascorp™, and can provide supplemental safety data for the review process. At the same time, it will prevent a public health crisis in rural Arizona by replacing the dwindling supply of local antivenom before an BLA is approved.

Patients who arrive at the emergency clinic presenting with scorpion sting symptoms will be evaluated for treatment with Anascorp.

Each patient who qualifies for entry into the study, according to inclusion/exclusion criteria, is assigned a patient number in sequential order of entry. Approximately 100 patients could be enrolled in the study per year.

After informed consent has been obtained, a baseline history and physical will be obtained and documented in the patient's chart. This will include an evaluation of the symptoms of systemic scorpion envenomation. The patient's vital signs (blood pressure, pulse and respiration) will be taken. The patient will be questioned as to concomitant medications. Demographic data will also be collected.

Three vials of Anascorp will be administered in a total volume of 50 mL, intravenous over not less than 10 minutes or as permitted by IV access. If clinically indicated by systemic signs, a second dose (one vial) will be administered if clinically indicated by systemic signs. One additional dose may be administered 30 minutes later if indicated by clinically significant signs of envenomation. When clinically significant signs have been absent for at least 30 minutes, a final physical assessment will take place and the patient will be discharged to home.

Twenty four hours and fourteen days after Anascorp™ treatment, all patients will be monitored for signs and symptoms of adverse events, including acute hypersensitivity reactions (anaphylactic and/or anaphylactoid reactions) and delayed serum sickness. All patients who received study drug will be included in the final analyses.

For the individual patient, the study starts at the time the consent is signed and ends at the 14 day telephone interview. The outcome is assessed 14 days after discharge by telephone interview.

Concomitant therapy and medications may be used at any time as needed. All concomitant medication must be documented in the CRF from time of entry into the study until the 14 day follow up telephone interview..

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females of any age presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation
  • Signed written Informed Consent by patient or legal guardian

Exclusion Criteria:

  • Allergy to horse serum
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624078

Locations
United States, Arizona
Casa Grande Regional Medical Center
Casa Grande, Arizona, United States, 85222
Chandler Regional
Chandler, Arizona, United States, 85224
Southeast Arizona Medical Center
Douglas, Arizona, United States, 85260
Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Banner Thunderbird Medical Center
Glendale, Arizona, United States, 85306
Banner Baywood Medical Center
Mesa, Arizona, United States, 86206
Gila Health Resources
Morenci, Arizona, United States, 85540
Holy Cross Hospital
Nogales, Arizona, United States, 85621
John C. Lincoln
Phoenix, Arizona, United States, 85027
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
Mt. Graham Regional Medical Center
Safford, Arizona, United States, 85546
San Carlos Indian Hospital
San Carlos, Arizona, United States, 85550
Scottsdale Healthcare
Scottsdale, Arizona, United States, 85260
St. Mary's Hospital
Tucson, Arizona, United States, 85745
Tucson Medical Center
Tucson, Arizona, United States, 85712
University Medical Center
Tucson, Arizona, United States, 85724
Whiteriver IHS Hospital
Whiteriver, Arizona, United States, 85941
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
University of Arizona
Investigators
Principal Investigator: Leslie Boyer, M.D VIPER Institute
Study Chair: Walter Garcia, M.D Instituto Bioclon S.A. de C.V.
  More Information

Publications:
Responsible Party: Walter Garcia U. MD/Clinical Research Manager, Instituto Bioclon
ClinicalTrials.gov Identifier: NCT00624078     History of Changes
Other Study ID Numbers: AL-03/07
Study First Received: December 26, 2007
Last Updated: February 19, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Instituto Bioclon S.A. de C.V.:
faboterapics
treatment
scorpion sting
envenomation

Additional relevant MeSH terms:
Bites and Stings
Poisoning
Substance-Related Disorders
Wounds and Injuries
Antivenins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014