At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective, Randomized, Double-Blind, Controlled Study of Alacramyn® vs. Placebo in Pediatric Patients With Systemic Signs of Scorpion Sting Envenomation
In Brief
A Phase 3 clinical trial evaluating Antivenin Centruroides (scorpion) equine immune F(ab)2 and Placebo for Scorpion Sting Envenomation. Completed, enrolled 15 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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