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

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

  • By

  • Riccardo Bartoletti

  • Francesco Claps

  • Gabriele Tulone

  • Alessandro Perotti

  • Alessandro Zucchi

  • Niccolò Riccardi

  • Vincenzo Ficarra

  • Cosimo De Nunzio

  • Andrea Tubaro

  • Alchiede Simonato

  • June 10, 2022

  • 0 min

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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

ParameterValue/Statistic
Number of patients analyzed1150 total; 143 diabetic subgroup
Period of study2017–2019
Incidence of infective complications in diabetic patientsIncreased risk with OR 2.037 (multivariate analysis)
Infective complications rate in trans-perineal biopsy cohort1.87%
Febrile infections post-TRUSPB2.8%
Hospitalization due to infection post-TRUSPB4%
Mortality due to sepsis post-TRUSPB0.12%
Antibiotic prophylaxis regimens usedCefixime, trimethoprim–sulphametoxazole, levofloxacin, prulifloxacin, ciprofloxacin, ceftriaxone/fosfomycin (augmented)

Key Findings

  • 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

  1. EMA Warning 2018 -- Restrictions on Fluoroquinolone Use
  2. European Association of Urology Guidelines 2019 -- Prostate Biopsy Prophylaxis
  3. Ding et al. 2020 -- Infection Risk Factors in Trans-perineal Prostate Biopsy
  4. Wu et al. 2019 -- Risk Factors for Infection Post-TRUSPB
  5. Multi-center Cohort Study 2017-2019 -- Antibiotic Prophylaxis and UTI Rates

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