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 - Report - MDSpire
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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
Impact of Fluoroquinolone Prophylaxis on UTI Rates Post-Prostate Biopsy in Diabetics
Overview
This observational cohort study analyzed 143 diabetic patients from a larger cohort undergoing trans-rectal ultrasound-guided prostate biopsy (TRUSPB) to assess the impact of different antibiotic prophylaxis regimens on urinary tract infection (UTI) rates during the EMA warning period against fluoroquinolones. The study found that diabetic patients had an increased risk of infective complications post-TRUSPB, and antibiotic resistance patterns influenced prophylaxis effectiveness.
Background
Urinary tract infections (UTIs) are a significant complication in patients with diabetes mellitus (DM), with higher rates of hospitalization and recurrence compared to non-diabetics. Trans-rectal ultrasound-guided prostate biopsy (TRUSPB) is a common diagnostic procedure for prostate cancer but carries a risk of infective complications, including UTIs. The European Medicine Agency (EMA) issued warnings restricting fluoroquinolone use for prophylaxis, leading to varied antibiotic regimens across centers. This study evaluates the impact of these prophylaxis changes on UTI rates in diabetic versus non-diabetic patients.
Data Highlights
Parameter
Value/Statistic
Number of patients analyzed
1150 total; 143 diabetic subgroup
Period of study
2017–2019
Incidence of infective complications in diabetic patients
Increased risk with OR 2.037 (multivariate analysis)
Infective complications rate in trans-perineal biopsy cohort
Diabetes mellitus is an independent risk factor for increased infective complications following TRUSPB, doubling the risk compared to non-diabetics.
Fluoroquinolone antibiotic prophylaxis was restricted during the EMA warning period, leading to adoption of alternative regimens such as cefixime and augmented prophylaxis with ceftriaxone/fosfomycin.
Antibiotic resistance to fluoroquinolones increased over the study period, impacting prophylaxis effectiveness.
Prophylaxis regimens were adapted based on renal function and local resistance patterns, highlighting the need for individualized approaches.
Patients with DM had higher rates of hospitalization and febrile infections post-TRUSPB compared to non-diabetics.
Pre-biopsy urine cultures and abdominal ultrasounds were used to exclude active infections before biopsy, ensuring accurate assessment of prophylaxis impact.
Clinical Implications
Clinicians should recognize diabetes mellitus as a significant risk factor for post-TRUSPB infections and consider this when selecting antibiotic prophylaxis. Given rising fluoroquinolone resistance and EMA restrictions, alternative prophylactic regimens tailored to local resistance patterns and patient renal function are essential to reduce infective complications. Pre-procedure screening for urinary infections remains critical to optimize outcomes.
Conclusion
This multi-center observational study underscores the increased risk of urinary tract infections in diabetic patients undergoing TRUSPB and highlights the challenges posed by fluoroquinolone restrictions and antibiotic resistance. Tailored antibiotic prophylaxis strategies are necessary to mitigate infective complications in this high-risk population.
References
EMA Warning 2018 -- Restrictions on Fluoroquinolone Use
European Association of Urology Guidelines 2019 -- Prostate Biopsy Prophylaxis
Ding et al. 2020 -- Infection Risk Factors in Trans-perineal Prostate Biopsy
Wu et al. 2019 -- Risk Factors for Infection Post-TRUSPB
Multi-center Cohort Study 2017-2019 -- Antibiotic Prophylaxis and UTI Rates