Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection

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 not possible for at least two days. It is unclear what the optimal management approach should be while awaiting the results of diagnostic tests. In some circumstances, broad spectrum antibiotics are started with a plan to adjust them once the results of cultures are available. Observational studies show that this results in greater antibiotic use, and the risk of superinfection and resistance. In other circumstances, antibiotics may be withheld pending the results of cultures, a strategy that leads to a delay in therapy when cultures are positive, and that may be associated with a worse clinical outcome.

We undertook a randomized pilot study to address the question: "In a critically ill patient for whom clinicians are uncertain whether infection may be present, and in whom potential sites of infection have been managed by removing or changing invasive devices, can a policy of delaying antibiotic treatment until cultures are available reduce the risks of excessive antibiotic use, without increasing the risks associated with delayed therapy?"

Recognizing that the question has not been formally addressed before, and that approaches to clinical management are both widely divergent and passionately held, our pilot study tested the feasibility and acceptability of undertaking a larger trial with sufficient power to determine equivalence.

Conditions

• Nosocomial Infection
• Pneumonia
• Systemic Inflammatory Response Syndrome
• Critical Illness
• Pyrexia

Interventions

DRUG

Site-specific empiric regimens included: Meropenem

DRUG

Piperacillin/tazobactam

DRUG

Ciprofloxacin and cefazolin +/- metronidazole

Sponsors & Collaborators

• The Physicians' Services Incorporated Foundation

  collaborator OTHER

• Canadian Critical Care Trials Group

  lead OTHER

Principal Investigators

• Mary-Anne W Aarts, MD MSc · University of Toronto

• John C Marshall, MD · University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-02-28

Completion

2005-03-31

Countries

• Canada

Study Locations