A Phase 3 interventional study of Anascorp in Scorpion Sting, sponsored by Instituto Bioclon S.A. de C.V.. Completed at 3 sites in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by Instituto Bioclon S.A. de C.V. · Phase 3, Interventional, and Treatment
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.
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.
112 studies on the registry are indexed under Bites and Stings; 45 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 89 interventional studies indexed under Bites and Stings.
Browse Bites and Stings studies →Instituto Bioclon S.A. de C.V. is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Also known as: Antivenin Centruroides (scorpion) equine immune F(ab')2
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
Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.
Time frame: One hour
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Instituto Bioclon S.A. de C.V.