Clinical Trial: Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
Brief Summary:
This treatment protocol will enable therapeutic use of Anascorp in the management of systemic manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise be unavailable. The working hypotheses are as follows:
- The investigational antivenom is safe as treatment of scorpion sting envenomation.
- The investigational antivenom is effective as treatment of scorpion sting envenomation.
Detailed Summary:
The purpose of this Open Label, Multi-Center Treatment Protocol, phase III trial is to examine the safety and efficacy of Anascorp, for treatment of patients envenomed by scorpion sting.
The treatment protocol, including up to 25 Arizona sites, increases the total number of subjects receiving Anascorp™, and can provide supplemental safety data for the review process. At the same time, it will prevent a public health crisis in rural Arizona by replacing the dwindling supply of local antivenom before an BLA is approved.
Patients who arrive at the emergency clinic presenting with scorpion sting symptoms will be evaluated for treatment with Anascorp.
Each patient who qualifies for entry into the study, according to inclusion/exclusion criteria, is assigned a patient number in sequential order of entry. Approximately 100 patients could be enrolled in the study per year.
After informed consent has been obtained, a baseline history and physical will be obtained and documented in the patient's chart. This will include an evaluation of the symptoms of systemic scorpion envenomation. The patient's vital signs (blood pressure, pulse and respiration) will be taken. The patient will be questioned as to concomitant medications. Demographic data will also be collected.
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. If clinically indicated by systemic signs, a second dose (one vial) will be administered if clinically indicated by systemic signs. One additional dose may be administered 30 minutes later if indicated by clinically significant signs of envenomation. When clinically significant
Sponsor: Instituto Bioclon S.A. de C.V.
Current Primary Outcome: Evaluate the adverse events profile of each patient [ Time Frame: immediately after treatment, 24 hrs and 14 days. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Resolution of systemic signs of scorpion envenomation [ Time Frame: after treatment ]
Original Secondary Outcome: Same as current
Information By: Instituto Bioclon S.A. de C.V.
Dates:
Date Received: December 26, 2007
Date Started: May 2005
Date Completion:
Last Updated: February 19, 2011
Last Verified: February 2011
