Complicated urinary tract infections treated with extended-release ciprofloxacin with emphasis on Pseudomonas aeruginosa
Abstract
This report focuses on the role of Pseudomonas aeruginosa in complicated urinary tract infections in a prospective, open-label, multicenter study designed to evaluate the safety and efficacy of extended-release ciprofloxacin (ciprofloxacin XR) 1000 mg once daily for 7-14 days for the treatment of complicated urinary tract infections. A total of 204 patients were valid for intention-to-treat analysis, of whom 130 were included in the clinical efficacy population. In the 56 microbiologically valid patients the bacteriological eradication rate was 82.1% and the clinical cure rate was 94.6%. Patients with P. aeruginosa infections valid for microbiological efficacy (n = 7) had 100% bacteriological eradication and clinical cure rates. In the intention-to-treat population, the bacteriological and clinical cure rates were 42.1% (51/121) and 55.9% (114/204), respectively. These rates were 58.3% and 75.0% respectively, for patients with P. aeruginosa infections. To achieve the desired 10 patients with P. aeruginosa for analysis, these data were pooled with data from a previous study. Treatment failure correlated with pre-therapy P. aeruginosa isolates being resistant to ciprofloxacin. On exploratory multivariate regression analysis, presence of neurogenic bladder, urinary retention owing to benign prostatic hypertrophy, prior urinary tract infection, and ischemic heart disease predicted P. aeruginosa infection.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 204 participants or records.
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