Urinary Tract Infections Clinical Trial
Official title:
A Pilot Concealed Randomized Double-blinded Placebo-controlled Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill
Urinary tract infection (UTI) is a common infection in patients in the intensive care unit
(ICU) that increases length of stay but not mortality. It is not known whether antibiotic
treatment will alter outcomes. Our previous studies have documented wide practice variations
exist amongst doctors, including prescribing antibiotics to asymptomatic patients.
Therefore, the merits of various ways to manage the infection require further studies to
minimize the potential for over-prescribing of antibiotics, a practice that can increase the
development of resistant bacteria.
The objective of this pilot study is to determine the feasibility of conducting a larger
definitive study that will determine the effect of catheter change and/or systemic
antibiotics as compared to no interventions on outcomes and resource utilization in ICU
patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone,
urine catheter change alone, and both catheter change and antibiotics. Their clinical
outcomes will be assessed.
Results from the pilot trial will provide information about whether it is feasible to
conduct the larger definitive trial. Results of the definitive study will provide guidance
to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.
n/a
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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