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Sponsors and Collaborators: |
Instituto Bioclon S.A. de C.V. University of Arizona |
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Information provided by: | Instituto Bioclon S.A. de C.V. |
ClinicalTrials.gov Identifier: | NCT00624078 |
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:
Condition | Intervention | Phase |
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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 |
Estimated Enrollment: | 600 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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.
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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..
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Leslie Boyer, M.D | (520) 626-6229 | boyer@pharmacy.arizona.edu |
Contact: Joanne Mallie, Nurse | (520) 626-5687 | mallie@pharmacy.arizona.edu |
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 |
Principal Investigator: | Leslie Boyer, M.D | VIPER Institute |
Study Chair: | Walter Garcia, M.D | Instituto Bioclon S.A. de C.V. |
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: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00624078 |
Health Authority: | United States: Food and Drug Administration |
faboterapics treatment scorpion sting envenomation |
Antivenins Wounds and Injuries Poisoning Disorders of Environmental Origin Bites and Stings |