Article Figures & Data
Figures
- Figure 1.
Study timeline.
- Figure 2.
Patient disposition. cUTI, complicated urinary tract infection; mITT, modified intent-to-treat; ME, microbiologically evaluable.
Tables
Neurogenic bladder or urinary retention Intermittent catheterization Partial obstruction, including: Kidney and/or bladder stone Renal tumor or fibrosis Distorted urethral structure Benign prostatic hypertrophy Inclusion Criteria Exclusion Criteria At least 105 colony-forming units of 1 or 2 uropathogens Uncomplicated UTI Acute pyelonephritis* One of the following: dysuria, increased urinary frequency, urgency, WBC >12,500/mm3 or ≥10% bands, temperature ≥100.4°F within the previous 24 hours Chronic pyelonephritis Complete obstruction Calculated creatinine clearance <50 mL/min Need for additional antimicrobial therapy for a coexisting infection or for the presenting UTI Need for or history of surgery or lithotripsy within 7 days of study entry Pathogen known to be resistant to the study medication Received >1 dose of any antibacterial for treatment of the UTI within 5 days of study entry (unless patient received at least 72 hours of a nonfluoroquinolone antibiotic and was deemed a clinical failure) Renal or perirenal abscess Acute or chronic bacterial prostatitis Epididymitis Pregnancy ↵* Additional exclusion criteria added for this study.
UTI, urinary tract infection; WBC, white blood cell.
Levofloxacin Ciprofloxacin Males (n = 105) Females (n = 118) Males (n = 119) Females (n = 85) Age (years) ≥60 66 (62.9) 69 (58.5) 84 (70.6) 48 (56.5) 30–59 33 (31.4) 39 (33.1) 32 (26.9) 32 (37.6) <30 6 (5.7) 10 (8.4) 3 (2.5) 5 (5.9) Race White 78 (74.3) 92 (78) 88 (74) 76 (89.4) Black 14 (13.3) 11 (9.3) 23 (19.3) 2 (2.4) Asian 2 (1.9) 0 (0) 0 (0) 2 (2.4) Hispanic 11 (10.5) 14 (11.9) 7 (5.9) 5 (5.8) Other 0 (0) 1 (0.8) 1 (0.8) 0 (0) Treatment setting Community 101 (96.2) 117 (99.2) 116 (97.5) 85 (100) Institutional 4 (3.8) 1 (0.8) 3 (2.5) 0 (0) Catheter use Intermittent/Straight 21 (20) 12 (10.2) 17 (14.3) 8 (9.4) Chronic indwelling 4 (3.8) 0 (0) 3 (2.5) 2 (2.4) Infection by most commonly occurring organisms Most common: Escherichia coli 50 (47.6) 75 (63.6) 68 (57.1) 59 (69.4) Second most common Enterococcus faecalis: 13 (12.4) Klebsiella pneumoniae: 16 (13.6) E. faecalis: 12 (10) K. pneumoniae: 15 (17.6) Third most common K. pneumoniae: 10 (9.5) Streptococcus agalactiae, Proteus mirabilis, E. faecalis (tie): 7 (6) K. pneumoniae: 10 (8.4) P. mirabilis: 3 (3.5) Infected with >1 pathogen 7 (6.7) 4 (3.4) 7 (5.9) 3 (3.5) Data are n (%).
- Table 4.
Comparison of Clinical Success Rates between Male and Female Patients with Complicated Urinary Tract Infection
Levofloxacin P Value Ciprofloxacin P Value Males Females Males Females EOT mITT 87/105 (83%) 95/118 (81%) .730 92/119 (77%) 66/85 (78%) 1.00 ME 79/91 (87%) 88/94 (94%) .141 84/98 (86%) 59/67 (88%) .817 Post-Therapy mITT 80/105 (76%) 96/118 (81%) .411 93/119 (78%) 70/85 (82%) .485 ME 74/91 (81%) 81/94 (86%) .428 84/98 (86%) 61/67 (91%) .342 EOT, end of therapy; ME, microbiologically evaluable; mITT, modified intent-to-treat.
- Table 5.
Clinical Success Rates for Male Patients with Complicated Urinary Tract Infection
Levofloxacin Ciprofloxacin P Value EOT mITT 87/105 (83%) 92/119 (77%) .321 ME 79/91 (87%) 84/98 (86%) .837 Post-Therapy mITT 80/105 (76%) 93/119 (78%) .752 ME 74/91 (81%) 84/98 (86%) .438 EOT, end of therapy; ME, microbiologically evaluable; mITT, modified intent-to-treat.
- Table 6.
Comparison of Clinical Success Rates within Complicating Factor Groups in the Microbiologically Evaluable Male Population at the End of Therapy, Based on Antibiotic Received
Levofloxacin Ciprofloxacin P Value Catheter use 21/23 (91.3%) 9/16 (56.3%) .019 No catheter 58/68 (85.3%) 75/82 (91.5%) .138 Neurogenic bladder or urinary retention 23/26 (88.5%) 18/26 (69.2%) .173 No neurogenic bladder or urinary retention 56/65 (86.2%) 66/72 (91.7%) .413 Partial obstruction (including BPH) 38/45 (84.4%) 43/48 (89.6%) .544 No obstruction 41/46 (89.1%) 41/50 (82%) .393 No additional complicating factors 30/34 (88.2%) 36/39 (92.3%) .698 ≥1 additional complicating factor 49/57 (85.9%) 48/59 (81.4%) .618 ≥2 additional complicating factors 26/30 (86.7%) 19/27 (70.4%) .195 BPH, benign prostatic hypertrophy.
- Table 7.
Comparison of Clinical Success Rates within Antibiotic Groups in the Microbiologically Evaluable Male Population at the End of Therapy, Based on Additional Complicating Factors
Antibiotic Complicating Factors P Value Catheter No catheter Levofloxacin 21/23 (91.3%) 58/68 (85.3%) .723 Ciprofloxacin 9/16 (56.3%) 75/82 (91.5%) .002 Neurogenic bladder or urinary retention No neurogenic bladder or urinary retention Levofloxacin 23/26 (88.5%) 56/65 (86.2%) 1.000 Ciprofloxacin 18/26 (69.2%) 66/72 (91.7%) .009 Partial obstruction (including BPH) No obstruction Levofloxacin 38/45 (84.4%) 41/46 (89.1%) .551 Ciprofloxacin 43/48 (89.6%) 41/50 (82%) .389 No additional complicating factors ≥2 Additional complicating factors Levofloxacin 30/34 (88.2%) 26/30 (86.7%) 1.000 Ciprofloxacin 36/39 (92.3%) 19/27 (70.4%) .040 BPH, benign prostatic hypertrophy.
