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

Scorpion Sting Envenomation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624078
• Other study ID #: AL-03/07
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 26, 2007
• Last updated: February 19, 2011
• Start date: May 2005
• Est. completion date: September 2010

Study information

• Verified date: February 2011
• Source: Instituto Bioclon S.A. de C.V.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1426
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bites and Stings
• Poisoning
• Scorpion Sting Envenomation
• Scorpion Stings

Intervention

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.

Locations

Country	Name	City	State
United States	Casa Grande Regional Medical Center	Casa Grande	Arizona
United States	Chandler Regional	Chandler	Arizona
United States	Southeast Arizona Medical Center	Douglas	Arizona
United States	Mercy Gilbert Medical Center	Gilbert	Arizona
United States	Banner Thunderbird Medical Center	Glendale	Arizona
United States	Banner Baywood Medical Center	Mesa	Arizona
United States	Gila Health Resources	Morenci	Arizona
United States	Holy Cross Hospital	Nogales	Arizona
United States	John C. Lincoln	Phoenix	Arizona
United States	Maricopa Medical Center	Phoenix	Arizona
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Mt. Graham Regional Medical Center	Safford	Arizona
United States	San Carlos Indian Hospital	San Carlos	Arizona
United States	Scottsdale Healthcare	Scottsdale	Arizona
United States	St. Mary's Hospital	Tucson	Arizona
United States	Tucson Medical Center	Tucson	Arizona
United States	University Medical Center	Tucson	Arizona
United States	Whiteriver IHS Hospital	Whiteriver	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Bioclon S.A. de C.V.	University of Arizona

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

Likes K, Banner W Jr, Chavez M. Centruroides exilicauda envenomation in Arizona. West J Med. 1984 Nov;141(5):634-7. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the adverse events profile of each patient		immediately after treatment, 24 hrs and 14 days.
Secondary	Resolution of systemic signs of scorpion envenomation		after treatment