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Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation

NCT01599923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2012-05-16

No results posted yet for this study

Summary

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.

Conditions

  • Scorpion Sting Envenomation

Interventions

BIOLOGICAL

Antivenin Centruroides (scorpion) equine immune F(ab')2

3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • Universidad Nacional Autonoma de Mexico

    collaborator OTHER

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-06-30
Completion
2006-08-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599923 on ClinicalTrials.gov