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Establishment of Natural History of Scorpion Envenomation

NCT ID: NCT00696683

Last Updated: 2008-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-07-31

Brief Summary

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This retrospective study was conducted to collect data from approximately 100 patients from 6 months to 18 years of age who were stung by a scorpion but were not treated with antivenom. The study consisted of a review of hospital records of patients who were admitted for intensive care management of scorpion envenomation, at the only two hospitals in North America known to admit children routinely for scorpion sting management without antivenom. The standard of care consisted of symptomatic and supportive care, including airway maintenance, fluid and electrolyte support and, if necessary, sedation.

Detailed Description

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The study objective was to document the clinical syndrome of scorpion envenomation in the absence of antivenom treatment in pediatric patients. This was done to establish historical control data on the time from sting to the time of resolution of signs of envenomation. These historical control data are intended to be used for comparison with Alacramyn treated patients in two prospective studies being conducted in Mexico and the U.S.for which a control population could not otherwise be established.

The total duration of clinically important systemic signs of envenomation was determined based upon overall investigator assessment of the last signs of any respiratory compromise, any pathological agitation or other indicator of continuing illness (e.g., continuing need for sedative administration).

To facilitate comparison of these historical data with prospective open label trials, periodic assessments of the overall presence or absence of clinically important signs was performed. Periodic assessments were also performed for each individual component indicator of respiratory compromise and of pathological agitation, when available.

A research nurse reviewed hospital discharge diagnoses for all pediatric charts coded for "scorpion sting". For these cases demographic, diagnostic, and therapeutic data were entered on the case report form (CRF) as well as data necessary to assess compliance with study inclusion and exclusion criteria.

A physician subinvestigator reviewed the research nurse's findings for the key outcome indicators, which consisted of clinically important systemic signs of scorpion envenomation and adjunctive sedation treatment (dose and timing of dose) when medical judgment was required.

Conditions

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Scorpion Sting Envenomation

Keywords

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scorpion sting envenomation antivenom

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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A

Patients from the identified scorpion envenomation cases, who met inclusion/exclusion criteria.

None, this is an observational study

Intervention Type OTHER

Interventions

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None, this is an observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Males and females 6 months to 18 years of age
* Presenting for emergency treatment with clinically important systemic signs of scorpion sting envenomation

Exclusion Criteria

* Use of any antivenom within the last month or concomitantly
* Signs and symptoms confined to local sting site
* Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy)
* Incomplete or unavailable medical record
Minimum Eligible Age

6 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role collaborator

Instituto Bioclon S.A. de C.V.

INDUSTRY

Sponsor Role lead

Responsible Party

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Instituto Bioclon S.A de C.V.

Principal Investigators

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Walter García, MD

Role: STUDY_CHAIR

Instituto Bioclon

Locations

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The University of Arizona Health Science Center & Tucson Medical Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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AL-03/06

Identifier Type: -

Identifier Source: org_study_id