Status:
COMPLETED
Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection
Lead Sponsor:
Canadian Critical Care Trials Group
Collaborating Sponsors:
The Physicians' Services Incorporated Foundation
Conditions:
Nosocomial Infection
Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Infection developing in the intensive care unit is a common complication of critical illness, but notoriously difficult to diagnose. A definite diagnosis based on the most reliable tests usually is no...
Detailed Description
We randomized critically ill patients who had been in hospital for at least 72 hours, and in the ICU for at least 24 hours, and who manifested either a temperature \>38.5 degrees, or a temperature\>38...
Eligibility Criteria
Inclusion
- In hospital \> 72 hrs and in ICU \> 24hrs, and
- Core temperature ≥38.5°C, or temperature ≥ 38.0°C with a WBC\>12,000/mm3, or temperature ≤ 36.0°C with a WBC \> 12,000/mm3
- Suspicion of infection
Exclusion
- Age \< 18 years
- Imminent death (within 24 hrs) or withdrawal of aggressive therapy
- Prosthetic heart valve or vascular graft
- Neutropenia (Absolute neutrophil count \< 1000/mm3)
- Received \> 16 hours of a broad spectrum antibiotic in the last 24 hours (3rd gen cephalosporin, fluoroquinolone, carbapenem, anti-pseudomonal penicillin) or any combination therapy
- History of allergic reaction to both study medications
- New physical findings consistent with infection:
- Meningeal signs
- Peritonitis + free air on Abdo x-ray
- Soft tissue infection / cellulitis
- Murmur \& suspicion of endocarditis
- Newly available (within past 24 hours) culture results consistent with infection
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2005
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00438269
Start Date
February 1 2003
End Date
March 1 2005
Last Update
February 22 2007
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2C4