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Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients

NCT00685230 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2011-06-02

No results posted yet for this study

Summary

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 such that the need for transport of most rural patients will be eliminated and will reduce hospitalization time.

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.

Conditions

  • Scorpion Sting Envenomation

Interventions

BIOLOGICAL

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

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

OTHER

Placebo

Placebo reconstituted in 50 ml of normal saline administered over 10 min

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

  • Leslie Boyer, MD · Poison and Drug Center

  • Walter Garcia, MD · Instituto Bioclon S.A. de C.V.

  • Alejandro Alagon, PhD · Universidad Nacional Autonoma de Mexico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2005-08-31
Completion
2005-10-31

Countries

  • United States

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 NCT00685230 on ClinicalTrials.gov