Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.
NCT ID: NCT03228108
Last Updated: 2022-05-10
Study Results
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Basic Information
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COMPLETED
PHASE4
1538 participants
INTERVENTIONAL
2018-04-03
2021-09-26
Brief Summary
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The investigators hypothesise that the targeted prophylaxis group (intervention group) will have a lower rate of post-biopsy infectious complications compared to the control group.
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Detailed Description
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Besides, in urology guidelines no clear recommendations are made on the duration of prophylaxis. In the Netherlands, therefore, various prophylactic ciprofloxacin schedules are used, of which 2 to 3 day regimens are most common. Prolonged duration of prophylaxis during prostate biopsy is not proven to be more effective than a 1-day regimen, but it is more likely to select more fluoroquinolone (FQ) resistance.
This study aims to assess the effectiveness and cost-effectiveness of rectal culture-guided antimicrobial prophylaxis to reduce infectious complications after transrectal prostate biopsy. Also, duration of antibiotic prophylaxis will be minimized to 24 hours, thereby controlling further development of resistant bacteria.
The culture method used in this study with four phenotypic screening agars to support the choice of one of the oral prophylactic antibiotics is innovative. Culture results become available rapidly, within 48 hours, the method is simple, relatively inexpensive, as it does not need full susceptibility testing of separate colonies, and useful in daily practice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Targeted antimicrobial prophylaxis
Men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prior to biopsy (equal to the active comparator arm), and men whose swabs do show ciprofloxacin-resistant bacteria will receive alternative oral antibiotics, based on culture results, in the following order:
* trimethoprim/sulfamethoxazole (SXT) 960 mg orally 2 hours before and 12 hours after prostate biopsy, or
* fosfomycin 3 g orally 2 hours before prostate biopsy, or
* pivmecillinam/augmentin respectively 400 mg and 500/125 mg 2 hours before prostate biopsy followed by 2 days with three divided doses each day after prostate biopsy.
Ciprofloxacin
see study arms.
Trimethoprim/Sulfamethoxazole
see study arms.
Fosfomycin
see study arms.
Pivmecillinam/augmentin
see study arms.
Routine empirical prophylaxis
Ciprofloxacin 500 mg orally 2 hours before and 12 hours after transrectal prostate biopsy.
Ciprofloxacin
see study arms.
Interventions
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Ciprofloxacin
see study arms.
Trimethoprim/Sulfamethoxazole
see study arms.
Fosfomycin
see study arms.
Pivmecillinam/augmentin
see study arms.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
90 Years
MALE
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Heiman Wertheim, Prof. dr.
Role: STUDY_DIRECTOR
Radboud University Medical Center
Locations
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Jeroen Bosch Hospital
's-Hertogenbosch, , Netherlands
Rijnstate
Arnhem, , Netherlands
Bravis
Bergen op Zoom, , Netherlands
Amphia Hospital
Breda, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Zuyderland Hospital
Heerlen, , Netherlands
Canisius Wilhelmina Hospital
Nijmegen, , Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Bravis
Roosendaal, , Netherlands
Zuyderland Hospital
Sittard, , Netherlands
Elisabeth Tweesteden Hospital
Tilburg, , Netherlands
Bernhoven Hospital
Uden, , Netherlands
Isala
Zwolle, , Netherlands
Countries
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References
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Tops SCM, Kolwijck E, Koldewijn EL, Somford DM, Delaere FJM, van Leeuwen MA, Breeuwsma AJ, de Vocht TF, Broos HJHP, Schipper RA, Steffens MG, Wegdam-Blans MCA, de Brauwer E, van den Bijllaardt W, Leenders ACAP, Sedelaar JPM, Wertheim HFL, Adang E. Cost Effectiveness of Rectal Culture-based Antibiotic Prophylaxis in Transrectal Prostate Biopsy: The Results from a Randomized, Nonblinded, Multicenter Trial. Eur Urol Open Sci. 2023 Feb 26;50:70-77. doi: 10.1016/j.euros.2023.02.006. eCollection 2023 Apr.
Tops SCM, Kolwijck E, Koldewijn EL, Somford DM, Delaere FJM, van Leeuwen MA, Breeuwsma AJ, de Vocht TF, Broos HJHP, Schipper RA, Steffens MG, Teerenstra S, Wegdam-Blans MCA, de Brauwer E, van den Bijllaardt W, Leenders ACAP, Sedelaar JPM, Wertheim HFL. Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial. Clin Infect Dis. 2023 Apr 3;76(7):1188-1196. doi: 10.1093/cid/ciac913.
Other Identifiers
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pro-SWAP104622
Identifier Type: -
Identifier Source: org_study_id
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