Study to reduce infectious complications prostate biopsy


PRO-SWAP study: the effect of rectal swab culture-guided antimicrobial prophylaxis in men undergoing prostate biopsy on infectious complications and cost of care: A randomized controlled trial in the Netherlands.  

Transrectal ultrasound-guided prostate biopsy (TRUS-PB) is a well established procedure to obtain tissue for the diagnosis of prostate cancer. Due to the transrectal approach of the procedure, it may be accompanied by infectious complications. In current guidelines, the antibiotic ciprofloxacin has been recommended as empirical prophylaxis in TRUS-PB. However, increased ciprofloxacin resistance in enterobacteria has resulted in an increase in infectious complications after TRUS-PB.

We will investigate a tailor-made antibiotic prophylaxis strategy based on resistance data of individual rectal cultures. This includes a pre-biopsy screening for ciprofloxacin resistant bacteria in the rectum of patients undergoing TRUS-PB, allowing the identification of men where ciprofloxacin prophylaxis is not appropriate. In these patients, alternative oral antimicrobial prophylaxis can be selected based on individual culture results. This personalized strategy is an innovative and unique approach to surgical prophylaxis in general.  

In our randomized controlled multicenter study we aim to assess the effectiveness and cost-effectiveness of rectal culture-guided antimicrobial prophylaxis to reduce infectious complications after TRUS-PB. To facilitate future implementation of targeted prophylaxis into daily clinical practice, a guideline on behalf of the Dutch Association of Urology will be developed. This guideline will not only include recommendations on appropriate targeted antimicrobial prophylaxis but also on how to organize and perform the proposed culture-directed strategy. The latter will be obtained from semi-structured interviews and focus groups among future users. 

This project, granted with € 577,000 subsidy from ZonMw will be conducted by the departments of Urology, Medical Microbiology, Hospital Pharmacy, IQ healthcare and Deaprtment for Health Evidence. The Radboudumc works together with the department of Microbiology of the PAMM and the department of Urology of the Catharina hospital and Elkerliek hospital in this project. 



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