Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
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.