Open Label, Confirmatory, Controlled Clinical Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
Sponsor study identifier
interventional
29
1 country
1
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2006
Actual (reported)Study Completion
August 2006
Actual (reported)There is no FDA approved therapy for the treatment of scorpion envenomation in the United States. 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 in the United States, 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.
August 2006
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.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 2006
Actual (reported)August 2006
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
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.
Children's Hospital of Morelos
Cuernavaca, Morelos, Mexico
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.
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.
Walter Garcia Ubbelohde, MD
Instituto Bioclon
Leslie V. Boyer, MD
VIPER Institute, University of Arizona
Neydi Osnaya, MD
Children's Hospital of Morelos
Alejandro Alagon, PhD
Universidad Nacional Autonoma de Mexico
29 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2012
First Posted
May 16, 2012
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
June 2006
Actual (reported)Study Completion
August 2006
Actual (reported)Last Updated
May 16, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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