Abstract
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.
Keywords
List of abbreviations:
AE (adverse event), CA-UTI (catheter-associated urinary tract infection), CI (confidence interval), EOT (end of therapy), MEDVAMC (Michael E. DeBakey Veterans Affairs Medical Center), SCI (spinal cord injury), UTI (urinary tract infection)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: September 13, 2013
Footnotes
Supported in part by the Department of Veterans Affairs, Rehabilitation Research and Development (grant no. B4747P) and the Dan L. Duncan Institute for Clinical and Translational Research.
Clinical Trial Registration No.: NCT00732238.
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.
Identification
Copyright
© 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
