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Complicated urinary tract infections treated with extended-release ciprofloxacin with emphasis on Pseudomonas
D Saltzstein1, B Wachs, R Perroncel
1Urology San Antonio Research, TX 78229, USA. beatrice.escamilla@urologysaresearch.com
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.
Insights
Extended-release ciprofloxacin effectively treated complicated urinary tract infections, showing high cure rates for Pseudomonas aeruginosa. Treatment failure was linked to ciprofloxacin resistance in P. aeruginosa infections.
Area of Science:
- Infectious Diseases
- Pharmacology
- Urology
Background:
- Complicated urinary tract infections (cUTIs) pose significant treatment challenges.
- Pseudomonas aeruginosa is a common pathogen in cUTIs, often associated with treatment failures.
- Extended-release ciprofloxacin offers a potential therapeutic option for cUTIs.
Purpose of the Study:
- To evaluate the safety and efficacy of extended-release ciprofloxacin (ciprofloxacin XR) for treating complicated urinary tract infections.
- To assess the treatment outcomes specifically in patients infected with Pseudomonas aeruginosa.
- To identify factors predicting P. aeruginosa infection and treatment failure.
Main Methods:
- Prospective, open-label, multicenter study.
- 204 patients with cUTIs received ciprofloxacin XR 1000 mg once daily for 7-14 days.
- Analysis included intention-to-treat (ITT) and clinical/microbiological efficacy populations, with pooled data for P. aeruginosa.
Main Results:
- Overall bacteriological eradication rate was 82.1% and clinical cure rate was 94.6% in microbiologically valid patients.
- In the ITT population, bacteriological and clinical cure rates were 42.1% and 55.9%, respectively.
- Patients with P. aeruginosa infections showed high eradication (100% in microbiologically valid, 58.3% in ITT) and cure rates (100% in microbiologically valid, 75.0% in ITT).
- Treatment failure correlated with pre-therapy ciprofloxacin resistance in P. aeruginosa isolates.
- Predictors for P. aeruginosa infection included neurogenic bladder, urinary retention due to benign prostatic hypertrophy, prior UTI, and ischemic heart disease.
Conclusions:
- Extended-release ciprofloxacin is safe and effective for treating complicated urinary tract infections, including those caused by P. aeruginosa.
- Ciprofloxacin resistance is a key factor in treatment failure for P. aeruginosa cUTIs.
- Identifying risk factors for P. aeruginosa can aid in targeted treatment strategies.
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