Clinical Trial: Open Label Clinical Trial of Anascorp® in Pediatric Patients With Scorpion Sting Envenomation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
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.
Detailed Summary:
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
Sponsor: Instituto Bioclon S.A. de C.V.
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment. [ Time Frame: One hour ]
Original Secondary Outcome: Same as current
Information By: Instituto Bioclon S.A. de C.V.
Dates:
Date Received: May 14, 2012
Date Started: April 2004
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016
