Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients
Condition: Scorpion Sting Envenomation
MeSH terms: Bites and Stings; Poisoning; Scorpion Stings
Study type: Interventional
Phase: Phase 2/Phase 3

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 such that the need for transport
      of most rural patients will be eliminated and will reduce hospitalization time.

      The working hypotheses are as follows:

        1. The investigational antivenom is safe as treatment of scorpion sting envenomation.

        2. The investigational antivenom is effective as treatment of scorpion sting envenomation.
    

Detailed description: 
      The purpose of this Prospective, Randomized, Double-Blind, Controlled, Multicenter Treatment
      Protocol, phase III trial is to examine the safety and efficacy of Alacramyn® for treatment
      of patients envenomed by scorpion sting.

      This study will take place in two pediatric Intensive care units in Tucson, Arizona.

      Patients who arrive at the emergency clinic presenting with scorpion sting symptoms will be
      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 will be included in the study. Baseline measures will include severity
      evaluation of the scorpion sting envenomation. The patient's vital signs, concomitant
      medication, medical history and demographic data will be collected. Blood tests will be done
      for haematology, chemistry, venom and anti-venom levels and urine test.

      After informed consent and inclusion7exclusion criteria have been obtained and verified, and
      the baseline measurements have been done, three vials of Alacramyn® or placebo will be
      administered. During the following 3 hours, midazolam will continue, if indicated for control
      of agitation.

      Patients off midazolam sedation after receiving study drug and no longer manifesting
      clinically important systemic signs of scorpion envenomation will be discharge at 4 hours, or
      2 hours following cessation of midazolam drip, whichever occurs later. Prior to discharge
      repeat lab work, physical assessments, and vital signs will be done. Patients still requiring
      midazolam sedation and/or manifesting clinically important systemic signs of scorpion
      envenomation will be treated with standard of care for the duration of clinical symptoms.
      Those remaining for extended care undergo final study assessments at time of hospital
      discharge or at 24 hours after study drug infusion if hospitalization continues.

      All patients who participated in the study will be 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; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 3 vials of Alacramyn reconstitued in 50 ml of normal saline as a IV infusion over 10 minutes.; Placebo reconstituted in 50 ml of normal saline administered over 10 min
Other intervention name(s): Anascorp
Intervention MeSH terms: Antivenins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: scorpion sting; envenomation; alacramyn