Scorpion Sting Envenomation Clinical Trial
Official title:
Treatment Protocol for Use of Anascorp™ in Patients With Scorpion Sting Envenomation
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:
1. The investigational antivenom is safe as treatment of scorpion sting envenomation.
2. The investigational antivenom is effective as treatment of scorpion sting envenomation.
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 signs have been absent for at least 30
minutes, a final physical assessment will take place and the patient will be discharged to
home.
Twenty four hours and fourteen days after Anascorp™ treatment, all patients will be monitored
for signs and symptoms of adverse events, including acute hypersensitivity reactions
(anaphylactic and/or anaphylactoid reactions) and delayed serum sickness. All patients who
received study drug will be included in the final analyses.
For the individual patient, the study starts at the time the consent is signed and ends at
the 14 day telephone interview. The outcome is assessed 14 days after discharge by telephone
interview.
Concomitant therapy and medications may be used at any time as needed. All concomitant
medication must be documented in the CRF from time of entry into the study until the 14 day
follow up telephone interview..
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01599923 -
Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
|
Phase 3 | |
| Completed |
NCT00685230 -
Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients
|
Phase 2/Phase 3 | |
| Completed |
NCT00696683 -
Establishment of Natural History of Scorpion Envenomation
|
N/A | |
| Completed |
NCT01599936 -
Open Label Clinical Trial of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
|
Phase 3 |