Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
Sponsor study identifier
interventional
50
1 country
3
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2006
Actual (reported)Study Completion
June 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
October 2006
Actual (reported)June 2007
Actual (reported)May 14, 2012
Actual (reported)May 16, 2012
Actual (reported)Resolution of clinically important systemic signs of scorpion envenomation within four hours after Alacramyn administration.
Assessments conducted at 1, 2 and 4 hours post administration
Demonstrate that venom blood levels will decrease within one hour after Alacramyn® treatment.
One hour
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
3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
San Carlos Indian Hospital
San Carlos, Arizona, 85550, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
University Medical Center
Tucson, Arizona, 85724, United States
Boyer LV, Theodorou AA, Berg RA, Mallie J; Arizona Envenomation Investigators; Chavez-Mendez A, Garcia-Ubbelohde W, Hardiman S, Alagon A. Antivenom for critically ill children with neurotoxicity from scorpion stings. N Engl J Med. 2009 May 14;360(20):2090-8. doi: 10.1056/NEJMoa0808455.
Likes K, Banner W Jr, Chavez M. Centruroides exilicauda envenomation in Arizona. West J Med. 1984 Nov;141(5):634-7.
Walter Garcia Ubbelohde, MD
Instituto Bioclon
Leslie V. Boyer, MD
VIPER Institute, University of Arizona
Alejandro Alagon, PhD
Universidad Nacional Autonoma de Mexico
50 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2012
First Posted
May 16, 2012
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Severity of Scorpion Sting in Relation to Hematological Parameters
Contact the study team to confirm eligibility.
Gibly R, Williams M, Walter FG, McNally J, Conroy C, Berg RA. Continuous intravenous midazolam infusion for Centruroides exilicauda scorpion envenomation. Ann Emerg Med. 1999 Nov;34(5):620-5. doi: 10.1016/s0196-0644(99)70164-2.
Berg RA, Tarantino MD. Envenomation by the scorpion Centruroides exilicauda (C sculpturatus): severe and unusual manifestations. Pediatrics. 1991 Jun;87(6):930-3. No abstract available.
LoVecchio F, Welch S, Klemens J, Curry SC, Thomas R. Incidence of immediate and delayed hypersensitivity to Centruroides antivenom. Ann Emerg Med. 1999 Nov;34(5):615-9. doi: 10.1016/s0196-0644(99)70176-9.
Curry SC, Vance MV, Ryan PJ, Kunkel DB, Northey WT. Envenomation by the scorpion Centruroides sculpturatus. J Toxicol Clin Toxicol. 1983-1984;21(4-5):417-49. doi: 10.3109/15563658308990433.
Primary Completion
October 2006
Actual (reported)Study Completion
June 2007
Actual (reported)Last Updated
March 22, 2016
Record last verified: 2016-03
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Source: ClinicalTrials.gov.
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