Antibiotic prophylaxis in patients who had undergone to prostate biopsy in between the EMA warning era: effects of fluoroquinolones in diabetic and non-diabetic patients. Results of an observational cohort study.

Purpose: To investigate the effects of different antibiotic prophylaxis regimens in patients with diabetes mellitus (DM) candidates to trans-rectal ultrasound-guided prostate biopsy (TRUSPB).

Methods: 143 outpatients with DM who underwent TRUSPB during the period 2018-2020 were selected from a cohort of 1150 patients in 3 different institutions. Exclusion criteria were allergies, concomitant anti-platelet therapies and uncontrolled DM. Different antibiotic prophylaxis regimens were adopted. Bacterial resistance levels to fluoroquinolones into the different communities were also collected. Univariable and multivariable binomial logistic regression analyses were used to assess the odds ratio (OR) with 95% confidence intervals (CIs) testing the risk of infective complications' occurrence after adjusting for clinical covariates.

Results: Overall, DM patients were significantly associated with infective complications' occurrence (p < 0.001). No differences on the event of sepsis were found between diabetic and non-diabetic patients. Clinically relevant infections with fever > 37 °C were found in 9.1% and 1.5% (p < 0.001) in diabetic and non-diabetic patients, respectively. Trimethoprim-sulphametoxazole and fluoroquinolones were six times more efficient than Cefixime in non-diabetic patients. Fluoroquinolones confirmed the same effect in diabetic patients although the level of resistance in the period of study decreased only from 56 to 46%.

Conclusion: Fluoroquinolones were active in antibiotic prophylaxis of diabetic patients who had undergone to TRUSPB independently from the level of bacterial resistance found in the community. These results conflict with the recent European warning and support the Japanese and American guidelines on the topic.