Prulifloxacin: a review focusing on its use beyond respiratory and urinary tract infections.

Prulifloxacin is a fluoroquinolone antibiotic that has been approved in several European countries for the treatment of lower urinary tract infections and exacerbations of chronic bronchitis. In this review, PubMed and Scopus databases were searched for potential uses of prulifloxacin beyond respiratory and urinary tract infections. Nine individual articles (eight randomised controlled trials and one cohort study) were regarded as eligible for inclusion in the review. Three of the studies were double-blinded, whilst six were open-label trials. Three studies referred to the treatment of patients with chronic bacterial prostatitis (CBP), one to prophylaxis of patients undergoing transrectal prostate biopsy, one to prophylaxis of women undergoing surgical abortion, two to patients with traveller's diarrhoea, one to diabetic patients with soft tissue infections or osteomyelitis, and one to improving tolerance of Bacillus Calmette-Guérin (BCG) instillations in patients with bladder cancer. Regarding CBP, prulifloxacin was non-inferior to its comparators, with a trend towards better microbiological outcomes at follow-up. Regarding traveller's diarrhoea, prulifloxacin resulted in better clinical and microbiological outcomes compared with placebo. Finally, prulifloxacin decreased the adverse events associated with BCG instillations in patients with bladder cancer, without affecting cancer recurrence rates. In summary, prulifloxacin appears to be a promising agent for the treatment of bacterial prostatitis and traveller's diarrhoea.

Patients included in randomised controlled trials do not represent those seen in clinical practice: focus on antimicrobial agents.

Clinicians rely on the findings of randomised controlled trials (RCTs) to formulate clinical decisions regarding individual patients. We examined whether patients included in RCTs focusing on antimicrobial agents are representative of those encountered in real-life clinical situations. PubMed was searched for RCTs referring to the field of infectious diseases. Data regarding the exclusion criteria of the identified RCTs were extracted and critically evaluated. In total, 30 trials (17 referring to respiratory tract, 5 to skin and soft-tissue, 4 to intra-abdominal, 2 to gynaecological and 2 to bloodstream infections) were included in the study. All retrieved RCTs reported extensive exclusion criteria. After comparing in a qualitative manner (based on our clinical experience) the eligible patient population in the identified RCTs with the respective population that would be encountered in general practice, it was observed that the abovementioned patient populations differ considerably. In conclusion, RCTs in the field of infectious diseases use extensive and stringent exclusion criteria, a fact that may lead to considerable difference between the patient populations of RCTs and those viewed in clinical practice. The application of the findings of RCTs to the care of individual patients should be performed cautiously.