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

NCT00624078 | Completed Phase 2

• 1 other identifier: AL-03/07
• Study Type: interventional
• Target: 1,426
• Locations: 1 country
• Sites: 18

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

Conditions

Scorpion Sting Envenomation

Keywords

faboterapics; treatment; scorpion sting; envenomation

Outcome Measures

Primary Outcomes (1)

• Evaluate the adverse events profile of each patient

  immediately after treatment, 24 hrs and 14 days.

Secondary Outcomes (1)

• Resolution of systemic signs of scorpion envenomation

  after treatment

Study Arms (1)

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™

Interventions

Antivenin Centruroides (scorpion) F(ab)2 Anascorp™ DRUG

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergy to horse serum

Sponsors & Collaborators

• Instituto Bioclon S.A. de C.V.: lead
• University of Arizona: collaborator

Study Sites (18)

Casa Grande Regional Medical Center

Casa Grande, Arizona, 85222, United States

Location

Chandler Regional

Chandler, Arizona, 85224, United States

Location

Southeast Arizona Medical Center

Douglas, Arizona, 85260, United States

Location

Mercy Gilbert Medical Center

Gilbert, Arizona, 85297, United States

Location

Banner Thunderbird Medical Center

Glendale, Arizona, 85306, United States

Location

Banner Baywood Medical Center

Mesa, Arizona, 86206, United States

Location

Gila Health Resources

Morenci, Arizona, 85540, United States

Location

Holy Cross Hospital

Nogales, Arizona, 85621, United States

Location

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

John C. Lincoln

Phoenix, Arizona, 85027, United States

Location

Mt. Graham Regional Medical Center

Safford, Arizona, 85546, United States

Location

San Carlos Indian Hospital

San Carlos, Arizona, 85550, United States

Location

Scottsdale Healthcare

Scottsdale, Arizona, 85260, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

University Medical Center

Tucson, Arizona, 85724, United States

Location

St. Mary's Hospital

Tucson, Arizona, 85745, United States

Location

Whiteriver IHS Hospital

Whiteriver, Arizona, 85941, United States

Location

Related Publications (5)

• Vazquez H, Chavez-Haro A, Garcia-Ubbelohde W, Mancilla-Nava R, Paniagua-Solis J, Alagon A, Sevcik C. Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers. Toxicon. 2005 Dec 1;46(7):797-805. doi: 10.1016/j.toxicon.2005.08.010. Epub 2005 Sep 28.

  PMID: 16197974 BACKGROUND

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

  PMID: 6516334 BACKGROUND

• 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. doi: 10.1080/15563650600907165.

  PMID: 17015284 BACKGROUND

• 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. doi: 10.1016/s0196-0644(99)70164-2.

  PMID: 10533010 BACKGROUND

• 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. doi: 10.1016/j.annemergmed.2005.11.042. No abstract available.

  PMID: 16546632 BACKGROUND

MeSH Terms

Conditions

Scorpion Stings

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Leslie Boyer, M.D

  VIPER Institute

  PRINCIPAL INVESTIGATOR

• Walter Garcia, M.D

  Instituto Bioclon S.A. de C.V.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: February 26, 2008
• Study Start: May 1, 2005
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 23, 2011

Record last verified: 2011-02

Locations

US (18)