Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

Completed

• Conditions: Snake Envenomation

• Registration Number: NCT00927381
• Lead Sponsor: BTG International Inc.

Brief Summary

Retrospective observational review of severe envenomation treatment with CroFab

Detailed 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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rocky Mountain Poison and Drug Center; 🇺🇸 Denver, Colorado, United States