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. - PRO-SWAP

Radboud University Medical Center0 个研究点目标入组 1,618 人开始时间: 2017年12月14日最近更新: 2021年11月8日

试验速览

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•- Men suspect of prostate cancer undergoing transrectal prostate biopsy as part of standard of care, in the Radboud university medical center (Radboudumc), Catharina hospital or Canisius Wilhelmina hospital
•- Subject is able and willing to sign the Informed Consent Form.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 618

•- Inability to receive ciprofloxacin prophylaxis for any reason (e.g. documented history of sensitivity to medicinal products or excipients similar to those found in the antibiotic prophylaxis, relevant history or presence of cardiovascular disorders (specific relevant QTc time prolongation), relevant drug interaction).
•- Inability to receive either co-trimoxazole, fosfomycin and pivmecillinam/augmentin prophylaxis for any reason (e.g. documented history of sensitivity to medicinal products or excipients similar to those found in the antibiotic prophylaxis, relevant drug interaction).
•- Inability to understand the nature of the trial and the procedures required.
•- Individuals with an urinary tract infection or acute prostatitis within 14 days prior to transrectal prostate biopsy.
•- Individuals who received antibiotics within 14 days prior to transrectal prostate biopsy.
•- Individuals who fail to send a rectum swab to the microbiology laboratory.
•- Individuals whose rectal swab shows no growth on a Colombia blood agar (growth control).

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