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.
- Conditions
- screening op prostaatcarcinoom (d.m.v. prostaatbiopsie)prostate biopsyinfectious complications10004018
- Registration Number
- NL-OMON48812
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1538
- Subject undergoes a transrectal prostate biopsy as part of the standard care
in one of the participating (study) centers (because of suspicion of prostate
cancer).
- Subject is able and willing to sign the Informed Consent Form.
- 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 (CBP)
(growth control)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method