Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

Snake Envenomation Clinical Trial

Official title:

Retrospective Evaluation of Treatments and Outcomes Associated With Antivenom Therapy For Crotaline Snakebite - A Comparison Of Severe To Mild/Moderate Envenomations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00927381
• Other study ID #: MC03/03/05
• Status: Completed
• Start date: January 2005
• Est. completion date: January 2005

Study information

• Verified date: June 2022
• Source: BTG International Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Retrospective observational review of severe envenomation treatment with CroFab

Description:

The objective of this study is to use previously collected retrospective observational data to compare treatment and outcome in patients treated with CroFab who have a severe envenomation to those with a mild/moderate envenomation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must involve treatment of a human patient with CroFab between January 1, 2002 and December 31, 2004

• The record must contain all of the following:

1. Clinical signs/symptoms prior to the first dose of antivenom,

2. Documentation of all doses of antivenom used to treat the patient,

3. Indication of whether or not initial control was achieved with antivenom.

To be included in the Efficacy Evaluable Population (EEP) in the current analysis, each record must meet the following criteria:

• Must contain enough information to calculate a severity score based on the 7-point severity scale.

• All records were included in the Safety Population in the current analysis.

Exclusion Criteria:

• Any cases identified that do not meet the inclusion criteria were excluded, including cases not treated with CroFab.

Related Conditions & MeSH terms

• Poisoning
• Snake Bites
• Snake Envenomation

Locations

Country	Name	City	State
United States	Rocky Mountain Poison and Drug Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity score: in order to assess response to therapy, severity scores were calculated and compared across all recorded time points.		at baseline and following treatment with CroFab
Secondary	The presence of venom effects, comparison of venom effects over time, initial control of venom effects, recurrence of venom effects, and delayed onset of venom effects.		following treatment