Retrospective Evaluation of CroFab - Efficacy in Severe Envenomation

BTG

Status: Completed

Conditions: Snake Envenomation

Study type: Observational

Funder types: Other

Identifiers

NCT00927381

MC03/03/05

Details and patient eligibility

About

Retrospective observational review of severe envenomation treatment with CroFab

Full 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.

Enrollment: 247 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

247 participants in 2 patient groups

Severe envenomation

Description:

Patients with a calculated severity score of 5 or 6 were included in this group.

Minimal/Moderate Envenomation

Description:

Severity Score less than 5