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Trial record 6 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy. (pro-SWAP)

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ClinicalTrials.gov Identifier: NCT03228108
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : September 16, 2019
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University

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 participants will receive routine empirical prophylaxis with oral ciprofloxacin (control group), while the other half will receive rectal culture-guided oral antibiotic prophylaxis (intervention group). In the intervention group, men whose rectal swabs do not show ciprofloxacin-resistant bacteria will receive ciprofloxacin prophylaxis, comparable to the control group. In case of ciprofloxacin-resistant bacteria an alternative oral antibiotic based on the culture results will be prescribed (trimethoprim/sulfamethoxazole, fosfomycin or pivmecillinam/augmentin).

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.


Condition or disease Intervention/treatment Phase
Complication Infection Prostate Cancer Drug: Ciprofloxacin Drug: Trimethoprim/Sulfamethoxazole Drug: Fosfomycin Drug: Pivmecillinam/augmentin Phase 4

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. Ciprofloxacin has been best studied and is recommended as first choice prophylaxis in urology guidelines. However, due to increasing fluoroquinolone resistance in gram negative bacilli (currently more than 20% in E.coli), a significant increase up to 6% in infectious complications after transrectal prostate biopsy was recently noticed. Antibiotic treatment of these infections and hospitalization may account for increased health care associated costs and will contribute to the further development of antibiotic resistance.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Biopsy

Arm Intervention/treatment
Experimental: 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.
Drug: Ciprofloxacin
see study arms.
Other Name: Ciproxin

Drug: Trimethoprim/Sulfamethoxazole
see study arms.
Other Name: Co-trimoxazole

Drug: Fosfomycin
see study arms.
Other Name: Monuril

Drug: Pivmecillinam/augmentin
see study arms.
Other Names:
  • Selexid
  • Amoxicillin/clavulanic acid

Active Comparator: Routine empirical prophylaxis
Ciprofloxacin 500 mg orally 2 hours before and 12 hours after transrectal prostate biopsy.
Drug: Ciprofloxacin
see study arms.
Other Name: Ciproxin




Primary Outcome Measures :
  1. Any registered clinical infectious complication after prostate biopsy [ Time Frame: within 7 days post-biopsy ]
    Urinary tract infection, pyelonephritis, sepsis, fever, acute prostatitis, acute epididymitis


Secondary Outcome Measures :
  1. Cost of care [ Time Frame: within 30 days after prostate biopsy ]
    Difference of costs between the intervention and the control group

  2. Positive microbiological results [ Time Frame: within 7 and 30 days after prostate biopsy ]
    Urine or blood culture results

  3. Any registered clinical infectious complication after prostate biopsy [ Time Frame: within 7 and 30 days after prostate biopsy ]
    Urinary tract infection, pyelonephritis, sepsis, fever, acute prostatitis, acute epididymitis

  4. Hospitalization after prostate biopsy [ Time Frame: within 30 days after prostate biopsy ]
    Any hospital admission, including ICU admission

  5. Overall mortality [ Time Frame: within 30 days after prostate biopsy ]
    Mortality of any cause

  6. Side effects of used antibiotics [ Time Frame: within 30 days after prostate biopsy ]
    All side effects mentioned in the Summary of Product Characteristics (SPC)

  7. Prevalence of ciprofloxacin-resistant gram negative bacilli in local rectal flora [ Time Frame: rectal swabs are taken 14 days before biopsy ]
    Assessed through microbiological rectal swab cultures

  8. Overall antibiotic use after prostate biopsy [ Time Frame: within 30 days after prostate biopsy ]
    Number of antibiotic prescriptions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228108


Contacts
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Contact: Eva Kolwijck, Dr. +31243614356 eva.kolwijck@radboudumc.nl
Contact: Sofie Tops-van Kuppevelt, Drs. +31243614356 sofie.tops@radboudumc.nl

Locations
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Netherlands
Jeroen Bosch Hospital Recruiting
's-Hertogenbosch, Netherlands
Contact: Paul Veenboer, Dr.         
Principal Investigator: Rob Schipper, Dr.         
Rijnstate Not yet recruiting
Arnhem, Netherlands
Contact: Michael van Balke, Dr.         
Bravis Not yet recruiting
Bergen Op Zoom, Netherlands
Contact: Sander van Leeuwen, Dr.         
Amphia Hospital Not yet recruiting
Breda, Netherlands
Contact: Deric van der Schoot, Dr.         
Catharina Hospital Recruiting
Eindhoven, Netherlands
Contact: Evert Koldewijn, Dr.         
Zuyderland Hospital Recruiting
Heerlen, Netherlands
Contact: Filip Delaere, Dr.         
Canisius Wilhelmina Hospital Recruiting
Nijmegen, Netherlands
Contact: Rik Somford, Dr.         
Radboud University Medical Center Recruiting
Nijmegen, Netherlands
Contact: Eva Kolwijck, Dr.    +31243614356    eva.kolwijck@radboudumc.nl   
Contact: Sofie Tops-van Kuppevelt, Drs.    +31243614356    sofie.tops@radboudumc.nl   
Principal Investigator: Michiel Sedelaar         
Bravis Not yet recruiting
Roosendaal, Netherlands
Contact: Sander van Leeuwen, Dr.         
Zuyderland Hospital Recruiting
Sittard, Netherlands
Contact: Filip Delaere, Dr.         
Elisabeth Tweesteden Hospital Recruiting
Tilburg, Netherlands
Contact: Anton Breeuwsma, Dr.         
Bernhoven Hospital Recruiting
Uden, Netherlands
Contact: Thijn de Vocht, Dr.         
Isala Recruiting
Zwolle, Netherlands
Contact: Martijn Steffens, Dr.         
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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Study Director: Heiman Wertheim, Prof. dr. Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03228108     History of Changes
Other Study ID Numbers: pro-SWAP104622
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radboud University:
Culture-guided
Targeted prophylaxis
Prostate biopsy
Antibiotic prophylaxis
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Dyskinesia Agents
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ciprofloxacin
Fosfomycin
Amoxicillin-Potassium Clavulanate Combination
Amdinocillin Pivoxil
Trimethoprim
Sulfamethoxazole
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antimalarials
Folic Acid Antagonists
Cytochrome P-450 CYP2C8 Inhibitors