title: Short versus long course of antibiotics for catheter-associated urinary tract infections in patients with spinal cord injury: a randomized controlled noninferiority trial.
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).
  
  
  METHODS
  Randomized, controlled, noninferiority trial.
  
  
  METHODS
  Medical center.
  
  
  METHODS
  Patients with SCI who had CA-UTI (N=61).
  
  
  METHODS
  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%.
  
  
  METHODS
  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.
authors.affiliation: 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.
authors.forename: Rabih O
authors.initials: RO
authors.lastname: Darouiche
authors.affiliation: Department of Medicine, University of Arizona, Tucson, AZ. Electronic address: malmohajer@email.arizona.edu.
authors.forename: Mayar
authors.initials: M
authors.lastname: Al Mohajer
authors.affiliation: Section of Infectious Diseases, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX; Department of Medicine, Baylor College of Medicine, Houston, TX.
authors.forename: Danish M
authors.initials: DM
authors.lastname: Siddiq
authors.affiliation: Dan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, TX.
authors.forename: Charles G
authors.initials: CG
authors.lastname: Minard
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D020878:Device Removal; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013119:Spinal Cord Injuries / Q000150:complications*; D016896:Treatment Outcome; D014546:Urinary Catheterization / Q000009:adverse effects*; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000209:etiology* / Q000382:microbiology
chemical_list: D000900:Anti-Bacterial Agents
keywords: AE; CA-UTI; CI; Catheters; EOT; MEDVAMC; Michael E. DeBakey Veterans Affairs Medical Center; Rehabilitation; SCI; Spinal cord injuries; UTI; Urinary tract infections; adverse event; catheter-associated urinary tract infection; confidence interval; end of therapy; spinal cord injury; urinary tract infection