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Open Label Clinical Trial of Anascorp® in Pediatric Patients With Scorpion Sting Envenomation

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ClinicalTrials.gov Identifier: NCT01599936
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : March 22, 2016
Sponsor:
Collaborators:
University of Arizona
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.

Brief Summary:
There is no FDA approved therapy for the treatment of scorpion envenomation. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms early in the clinical course while avoiding the clinical deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than the present standard of care, midazolam, and faster-acting thus eliminating the need to transport most rural patients and reducing hospitalization time.

Condition or disease Intervention/treatment Phase
Scorpion Sting Biological: Anascorp Phase 3

Detailed Description:

The purpose of this open label, confirmatory, controlled clinical trial was to examine the safety and efficacy of Alacramyn® for treatment of patients envenomed by scorpion sting.

This study took place at San Carlos Indian Hospital in San Carlos, Arizona and in two pediatric Intensive care units in Tucson, Arizona.

Patients who arrived at the emergency department presenting with scorpion sting symptoms were evaluated for treatment with respect to the inclusion/exclusion criteria according to the study procedures. Only patients with clinically important systemic signs of scorpion sting envenomation were included in the study. Baseline measures included severity evaluation of the scorpion sting envenomation. The patient's vital signs, concomitant medication, medical history and demographic data were collected. Blood tests were done for haematology, chemistry, venom and anti-venom levels and urine test.

After informed consent and inclusion/exclusion criteria were obtained and verified, and the baseline measurements completed, three vials of Alacramyn® were administered. At the one hour assessment an additional vial of Alacramyn® was administered if important systemic signs of scorpion envenomation were present. The assessment was repeated at two hours and a final vial of Alacramyn® was administered if deemed necessary. Patient were discharged after the 4 hour assessment if symptoms were resolved. Prior to discharge repeat lab work, physical assessments, and vital signs were done. Those remaining for extended care underwent final study assessments at time of hospital discharge or at 24 hours after study drug infusion if hospitalization continued.

All patients who participated in the study were contacted 7 and 14 days after treatment, looking for symptoms suggestive of ongoing venom effect, delayed serum sickness, as well as for any other adverse event reported by the patient.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
Study Start Date : April 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : June 2007

Arm Intervention/treatment
Experimental: Anascorp
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
Biological: Anascorp
3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
Other Name: Antivenin Centruroides (scorpion) equine immune F(ab')2




Primary Outcome Measures :
  1. Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration. [ Time Frame: Assessments conducted at 1, 2 and 4 hours post administration ]

Secondary Outcome Measures :
  1. Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment. [ Time Frame: One hour ]


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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 6 months to 18 years of age
  • Presenting for emergency care within 5 hours with clinically important signs of scorpion sting envenomation
  • Signed written Informed Consent by parent or legal guardian
  • No participation in a clinical drug trial within the last month or concomitantly

Exclusion Criteria:

  • Allergy to horse serum
  • Use within the past 24 hours of drugs expected to alter immune response
  • Use of any antivenom within the last month or concomitantly
  • Underlying medical condition that significantly alters immune response
  • Concurrent medical condition involving a baseline neurological status mimicking envenomation
  • Pregnant and nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599936


Locations
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United States, Arizona
San Carlos Indian Hospital
San Carlos, Arizona, United States, 85550
Tucson Medical Center
Tucson, Arizona, United States, 85712
University Medical Center
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
University of Arizona
Universidad Nacional Autonoma de Mexico
Investigators
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Study Director: Walter Garcia Ubbelohde, MD Instituto Bioclon
Principal Investigator: Leslie V. Boyer, MD VIPER Institute, University of Arizona
Study Chair: Alejandro Alagon, PhD Universidad Nacional Autonoma de Mexico

Additional Information:
Publications:
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Responsible Party: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01599936     History of Changes
Other Study ID Numbers: AL-02/06
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
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Bites and Stings
Scorpion Stings
Poisoning
Chemically-Induced Disorders
Wounds and Injuries