Status:
COMPLETED
Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Complication
Infection
Eligibility:
MALE
18-90 years
Phase:
PHASE4
Brief Summary
This study aims to assess the effectiveness and cost-effectiveness of rectal swab culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Half of...
Detailed Description
Several classes of antibiotics are proven effective for prophylaxis during transrectal prostate biopsy, reducing infectious complications to less than 1% in case of susceptible rectal flora. Ciproflox...
Eligibility Criteria
Inclusion
- Subject is able and willing to sign the Informed Consent Form.
- Subject undergoes a transrectal prostate biopsy as part of the standard care in the Radboudumc (Nijmegen), Canisius Wilhelmina hospital (Nijmegen) or Catharina hospital (Nijmegen) (because of suspicion of prostate cancer).
Exclusion
- Inability to receive ciprofloxacin (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)
- 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)
- 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 intervention.
- Individuals who receive antibiotics within 14 days before prostate biopsy.
- Individuals who fail to send a rectum swab to the microbiology laboratory.
- Individuals whose rectal swab shows no growth on a (growth) control MacConkey agar without antibiotics.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2021
Estimated Enrollment :
1538 Patients enrolled
Trial Details
Trial ID
NCT03228108
Start Date
April 3 2018
End Date
September 26 2021
Last Update
May 10 2022
Active Locations (13)
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1
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
2
Rijnstate
Arnhem, Netherlands
3
Bravis
Bergen op Zoom, Netherlands
4
Amphia Hospital
Breda, Netherlands