Open Label Clinical Trial of Anascorp® in Pediatric Patients With Scorpion Sting Envenomation
Completed · Phase 3
Conditions studied: Scorpion Sting
In brief
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 thus eliminating the need to transport most rural patients and reducing hospitalization time.
Key facts
- Study ID
- NCT01599936
- Run by
- Instituto Bioclon S.A. de C.V.
- People needed
- 50
- Starts
- 2004-04-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2016-03-22
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females 6 months to 18 years of age
- Presenting for emergency care within 5 hours with clinically important signs of scorpion sting envenomation
- Signed written Informed Consent by parent or legal guardian
- No participation in a clinical drug trial within the last month or concomitantly
You may not qualify if…
- Allergy to horse serum
- Use within the past 24 hours of drugs expected to alter immune response
- Use of any antivenom within the last month or concomitantly
- Underlying medical condition that significantly alters immune response
- Concurrent medical condition involving a baseline neurological status mimicking envenomation
- Pregnant and nursing women
Where it is running
- San Carlos Indian Hospital — San Carlos, Arizona, United States
- Tucson Medical Center — Tucson, Arizona, United States
- University Medical Center — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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