Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
Condition: Scorpion Sting Envenomation
MeSH terms: Bites and Stings; Poisoning; Scorpion Stings
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): Antivenin Centruroides (scorpion) equine immune F(ab')2
Intervention type(s): Biological
Intervention description(s): 3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
Other intervention name(s): Alacramyn; Anascorp
Intervention MeSH terms: Antivenins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: scorpion; envenomation; Alacramyn