Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

This study has been completed.
Sponsor:
Collaborators:
University of Arizona
Universidad Nacional Autonoma de Mexico
Information provided by (Responsible Party):
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT01599923
First received: May 14, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

There is no FDA approved therapy for the treatment of scorpion envenomation in the United States. 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 in the United States, midazolam, and faster-acting thus eliminating the need to transport most rural patients and reducing hospitalization time.


Condition Intervention Phase
Scorpion Sting Envenomation
Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

Resource links provided by NLM:


Further study details as provided by Instituto Bioclon S.A. de C.V.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment. [ Time Frame: One hour ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: May 2005
Study Completion Date: August 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alacramyn Biological: Antivenin Centruroides (scorpion) equine immune F(ab')2
3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
Other Names:
  • Alacramyn
  • Anascorp

Detailed Description:

The purpose of this open label, confirmatory, controlled clinical trial in Mexico was to provide additional data safety and efficacy of Alacramyn® for treatment of patients envenomed by scorpion sting.

This study took place at Morelos Children's Hospital in Cuernavaca, Mexico.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599923

Locations
Mexico
Children's Hospital of Morelos
Cuernavaca, Morelos, Mexico
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
University of Arizona
Universidad Nacional Autonoma de Mexico
Investigators
Study Director: Walter Garcia Ubbelohde, MD Instituto Bioclon
Principal Investigator: Leslie V. Boyer, MD VIPER Institute, University of Arizona
Principal Investigator: Neydi Osnaya, MD Children's Hospital of Morelos
Study Chair: Alejandro Alagon, PhD Universidad Nacional Autonoma de Mexico
  More Information

Publications:
Responsible Party: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier: NCT01599923     History of Changes
Other Study ID Numbers: AL-02/05
Study First Received: May 14, 2012
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bites and Stings
Poisoning
Substance-Related Disorders
Wounds and Injuries
Antivenins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014