OBJECTIVE: To assess the applicability of a short-course regimen of antibiotics for managing catheter-associated urinary tract infection (CA-UTI) in patients with spinal cord injury (SCI).
DESIGN: Randomized, controlled, noninferiority trial.
SETTING: Medical center.
PARTICIPANTS: Patients with SCI who had CA-UTI (N=61).
INTERVENTIONS: Patients were randomized to receive either a 5-day regimen of antibiotics after catheter exchange (experimental group) or a 10-day regimen of antibiotics with catheter retention (control group). Noninferiority was prespecified with a margin of 10%.
MAIN OUTCOME MEASURE: Clinical cure at the end of therapy.
RESULTS: Of the 61 patients enrolled in this study, 6 patients were excluded because of bacteremia or absence of urinary symptoms. All patients (100%) achieved clinical cure at the end of therapy. The rates of microbiologic response were 82.1% in the experimental group and 88.9% in the control group (upper boundary 95% confidence interval (CI) for difference, 26%). The rates of resolution of pyuria were 89.3% in the experimental group and 88.9% in the control group (upper boundary 95% CI for difference, 16%). Patients in the experimental group had higher rates of CA-UTI recurrence than the control group. The rates of new CA-UTI, diarrhea, and Clostridium difficile colitis were similar in the 2 treatment arms.
CONCLUSIONS: The primary endpoint of the study was met, indicating that the 5-day regimen with catheter exchange was noninferior to the 10-day regimen with catheter retention on the basis of clinical cure. Criteria for noninferiority on the basis of microbiologic response and resolution of pyuria were not met.
Darouiche RO, Al Mohajer M, Siddiq DM, Minard CG. Are you the author?
Spinal Cord Injury Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX; Section of Infectious Diseases, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX; Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, TX; Department of Medicine, Baylor College of Medicine, Houston, TX; Department of Medicine, University of Arizona, Tucson, AZ; Department of Medicine, Baylor College of Medicine, Houston, TX; Dan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX.
Reference: Arch Phys Med Rehabil. 2014 Feb;95(2):290-6.