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

Condition(s) targeted: Scorpion Sting Envenomation

Intervention: Antivenin Centruroides (scorpion) F(ab)2 Anascorp™ (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Instituto Bioclon S.A. de C.V.

Official(s) and/or principal investigator(s):
Leslie Boyer, M.D, Principal Investigator, Affiliation: VIPER Institute
Walter Garcia, M.D, Study Chair, Affiliation: Instituto Bioclon S.A. de C.V.

Overall contact:
Leslie Boyer, M.D, Phone: (520) 626-6229, Email: boyer@pharmacy.arizona.edu

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.

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

Study design: Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Evaluate the adverse events profile of each patient

Secondary outcome: Resolution of systemic signs of scorpion envenomation

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..

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Leslie Boyer, M.D, Phone: (520) 626-6229, Email: boyer@pharmacy.arizona.edu

Casa Grande Regional Medical Center, Casa Grande, Arizona 85222, United States; Recruiting
Cherie Adams, Nurse, Phone: 520-381-6285, Email: chadams@cox.net
Octavio Vidal, MD, Principal Investigator

Chandler Regional, Chandler, Arizona 85224, United States; Recruiting
Sue Hoopmann, Nurse, Phone: 480-728-3674, Email: Sue.Hoopmann@chw.edu
Joshua Zeidler, DO, Principal Investigator

Southeast Arizona Medical Center, Douglas, Arizona 85260, United States; Recruiting
Annie Benzon, Nurse
John Barberii, MD, Principal Investigator

Mercy Gilbert Medical Center, Gilbert, Arizona 85297, United States; Recruiting
Sue Hoopmann, Nurse, Phone: 480-728-3674, Email: Sue.Hoopmann@chw.edu
Joshua Zeidler, DO, Principal Investigator

Banner Thunderbird Medical Center, Glendale, Arizona 85306, United States; Recruiting
Mandy Childs, Nurse, Phone: 602-865-4886, Email: Mandy.Childs@bannerhealth.com
Trina Bogart, MD, Principal Investigator

Banner Baywood Medical Center, Mesa, Arizona 86206, United States; Recruiting
Kellie Bieber, Pharmacist, Phone: 480-321-4185, Email: kellie.beiber@bannerhealth.com
Duane Crist, MD, Principal Investigator

Gila Health Resources, Morenci, Arizona 85540, United States; Recruiting
Rhonda Samuelson, Nurse, Phone: 928-865-7534, Email: rsamuelson@gilahealth.com
Fred Fox, MD, Principal Investigator

Holy Cross Hospital, Nogales, Arizona 85621, United States; Not yet recruiting
Carol Hippenmeyer, MD, Phone: 520-405-3954, Email: fugitive@theriver.com
Carol Hippenmeyer, MD, Principal Investigator

John C. Lincoln, Phoenix, Arizona 85027, United States; Recruiting
Nancy Cahill, Nurse, Phone: 602-870-6060, Ext: 2266, Email: ncahil@jcl.com
Nelson Faux, MD, Principal Investigator

Phoenix Children's Hospital, Phoenix, Arizona 85016, United States; Recruiting
Stacey Mann, Nurse, Phone: 602-546-0160, Email: smann@phoenixchildrens.com
Michelle Ruha, MD, Principal Investigator

Maricopa Medical Center, Phoenix, Arizona 85008, United States; Recruiting
Vonnie Fuentes, Nurse, Phone: 602-344-5166, Email: Shelley.Fuentes@hcs.maricopa.gov
Frank LoVecchio, DO, Principal Investigator

Mt. Graham Regional Medical Center, Safford, Arizona 85546, United States; Recruiting
Jeannine Carpenter, Nurse, Phone: 928-348-4291, Email: jeanninec@mtgraham.org
Linda Miller, DO, Principal Investigator

San Carlos Indian Hospital, San Carlos, Arizona 85550, United States; Recruiting
Karen Heath, MD, Phone: 928-475-7219, Email: Karen.Heath@ihs.gov
Karen Heath, MD, Principal Investigator

Scottsdale Healthcare, Scottsdale, Arizona 85260, United States; Recruiting
Emily Shumway, Nurse, Phone: 480-323-3630, Email: EShumway@SHC.org
Alan Roga, MD, Principal Investigator

St. Mary's Hospital, Tucson, Arizona 85745, United States; Recruiting
Michael MacNeel, MD, Phone: 520-872-3000, Email: mmacneel@carondelet.org
Michael MacNeel, MD, Principal Investigator

Tucson Medical Center, Tucson, Arizona 85712, United States; Recruiting
Jody Mallie, Nurse, Phone: 520-626-5687, Email: mallie@pharmacy.arizona.edu
Andreas Theodorou, MD, Principal Investigator

University Medical Center, Tucson, Arizona 85724, United States; Recruiting
Jody Mallie, Nurse, Phone: 520-626-5687, Email: mallie@pharmacy.arizona.edu

Whiteriver IHS Hospital, Whiteriver, Arizona 85941, United States; Recruiting
Dwight Humpherys, MD, Phone: 928-338-3740, Email: Dwight.Humpherys@ihs.gov
Dwight Humpherys, DO, Principal Investigator

Related publications:

Vázquez H, Chávez-Haro A, García-Ubbelohde W, Mancilla-Nava R, Paniagua-Solís J, Alagón A, Sevcik C. Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers. Toxicon. 2005 Dec 1;46(7):797-805. Epub 2005 Sep 28.

Likes K, Banner W Jr, Chavez M. Centruroides exilicauda envenomation in Arizona. West J Med. 1984 Nov;141(5):634-7. No abstract available.

Lai MW, Klein-Schwartz W, Rodgers GC, Abrams JY, Haber DA, Bronstein AC, Wruk KM. 2005 Annual Report of the American Association of Poison Control Centers' national poisoning and exposure database. Clin Toxicol (Phila). 2006;44(6-7):803-932.

Gibly R, Williams M, Walter FG, McNally J, Conroy C, Berg RA. Continuous intravenous midazolam infusion for Centruroides exilicauda scorpion envenomation. Ann Emerg Med. 1999 Nov;34(5):620-5.

Riley BD, LoVecchio F, Pizon AF. Lack of scorpion antivenom leads to increased pediatric ICU admissions. Ann Emerg Med. 2006 Apr;47(4):398-9. No abstract available.

Starting date: May 2005
Last updated: September 29, 2010