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Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
This study is currently recruiting participants.
Verified by Instituto Bioclon S.A. de C.V., February 2009
First Received: December 26, 2007   Last Updated: February 18, 2009   History of Changes
Sponsors and Collaborators: Instituto Bioclon S.A. de C.V.
University of Arizona
Information provided by: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier: NCT00624078
  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 II
Phase III

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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 ]

Estimated Enrollment: 600
Study Start Date: May 2005
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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

Contacts
Contact: Leslie Boyer, M.D (520) 626-6229 boyer@pharmacy.arizona.edu
Contact: Joanne Mallie, Nurse (520) 626-5687 mallie@pharmacy.arizona.edu

Locations
United States, Arizona
Banner Baywood Medical Center Recruiting
Mesa, Arizona, United States, 86206
Contact: Kellie Bieber, Pharmacist     480-321-4185     kellie.beiber@bannerhealth.com    
Principal Investigator: Duane Crist, MD            
Banner Thunderbird Medical Center Recruiting
Glendale, Arizona, United States, 85306
Contact: Mandy Childs, Nurse     602-865-4886     Mandy.Childs@bannerhealth.com    
Principal Investigator: Trina Bogart, MD            
Casa Grande Regional Medical Center Recruiting
Casa Grande, Arizona, United States, 85222
Contact: Cherie Adams, Nurse     520-381-6285     chadams@cox.net    
Principal Investigator: Octavio Vidal, MD            
Chandler Regional Recruiting
Chandler, Arizona, United States, 85224
Contact: Sue Hoopmann, Nurse     480-728-3674     Sue.Hoopmann@chw.edu    
Principal Investigator: Joshua Zeidler, DO            
Gila Health Resources Recruiting
Morenci, Arizona, United States, 85540
Contact: Rhonda Samuelson, Nurse     928-865-7534     rsamuelson@gilahealth.com    
Principal Investigator: Fred Fox, MD            
Holy Cross Hospital Not yet recruiting
Nogales, Arizona, United States, 85621
Contact: Carol Hippenmeyer, MD     520-405-3954     fugitive@theriver.com    
Principal Investigator: Carol Hippenmeyer, MD            
John C. Lincoln Recruiting
Phoenix, Arizona, United States, 85027
Contact: Nancy Cahill, Nurse     602-870-6060 ext 2266     ncahil@jcl.com    
Principal Investigator: Nelson Faux, MD            
Maricopa Medical Center Recruiting
Phoenix, Arizona, United States, 85008
Contact: Vonnie Fuentes, Nurse     602-344-5166     Shelley.Fuentes@hcs.maricopa.gov    
Principal Investigator: Frank LoVecchio, DO            
Mercy Gilbert Medical Center Recruiting
Gilbert, Arizona, United States, 85297
Contact: Sue Hoopmann, Nurse     480-728-3674     Sue.Hoopmann@chw.edu    
Principal Investigator: Joshua Zeidler, DO            
Whiteriver IHS Hospital Recruiting
Whiteriver, Arizona, United States, 85941
Contact: Dwight Humpherys, MD     928-338-3740     Dwight.Humpherys@ihs.gov    
Principal Investigator: Dwight Humpherys, DO            
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Stacey Mann, Nurse     602-546-0160     smann@phoenixchildrens.com    
Principal Investigator: Michelle Ruha, MD            
San Carlos Indian Hospital Recruiting
San Carlos, Arizona, United States, 85550
Contact: Karen Heath, MD     928-475-7219     Karen.Heath@ihs.gov    
Principal Investigator: Karen Heath, MD            
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Emily Shumway, Nurse     480-323-3630     EShumway@SHC.org    
Principal Investigator: Alan Roga, MD            
Southeast Arizona Medical Center Recruiting
Douglas, Arizona, United States, 85260
Contact: Annie Benzon, Nurse            
Principal Investigator: John Barberii, MD            
St. Mary's Hospital Recruiting
Tucson, Arizona, United States, 85745
Contact: Michael MacNeel, MD     520-872-3000     mmacneel@carondelet.org    
Principal Investigator: Michael MacNeel, MD            
Tucson Medical Center Recruiting
Tucson, Arizona, United States, 85712
Contact: Jody Mallie, Nurse     520-626-5687     mallie@pharmacy.arizona.edu    
Principal Investigator: Andreas Theodorou, MD            
University Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Jody Mallie, Nurse     520-626-5687     mallie@pharmacy.arizona.edu    
Mt. Graham Regional Medical Center Recruiting
Safford, Arizona, United States, 85546
Contact: Jeannine Carpenter, Nurse     928-348-4291     jeanninec@mtgraham.org    
Principal Investigator: Linda Miller, DO            
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: Instituto Bioclon ( Walter Garcia U. MD/Clinical Research Manager )
Study ID Numbers: AL-03/07
Study First Received: December 26, 2007
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00624078     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Antivenins
Wounds and Injuries
Poisoning
Disorders of Environmental Origin
Bites and Stings

Additional relevant MeSH terms:
Wounds and Injuries
Poisoning
Disorders of Environmental Origin
Bites and Stings

ClinicalTrials.gov processed this record on September 04, 2009