Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

NCT03228108 | Completed Phase 4 DMC

• 1 other identifier: pro-SWAP104622
• Study Type: interventional
• Target: 1,538
• Locations: 1 country
• Sites: 13

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.

Conditions

Complication; Infection; Prostate Cancer

Keywords

Culture-guided; Targeted prophylaxis; Prostate biopsy; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• Any registered clinical infectious complication after prostate biopsy

  Urinary tract infection, pyelonephritis, sepsis, fever, acute prostatitis, acute epididymitis

  within 7 days post-biopsy

Secondary Outcomes (8)

• Cost of care

  within 30 days after prostate biopsy

• Positive microbiological results

  within 7 and 30 days after prostate biopsy

• Any registered clinical infectious complication after prostate biopsy

  within 7 and 30 days after prostate biopsy

• Hospitalization after prostate biopsy

  within 30 days after prostate biopsy

• Overall mortality

  within 30 days after prostate biopsy

Study Arms (2)

Targeted antimicrobial prophylaxis

EXPERIMENTAL

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; Drug: Trimethoprim/Sulfamethoxazole; Drug: Fosfomycin; Drug: Pivmecillinam/augmentin

Routine empirical prophylaxis

ACTIVE COMPARATOR

Ciprofloxacin 500 mg orally 2 hours before and 12 hours after transrectal prostate biopsy.

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

see study arms.

Also known as: Ciproxin

Routine empirical prophylaxis; Targeted antimicrobial prophylaxis

Trimethoprim/Sulfamethoxazole DRUG

see study arms.

Also known as: Co-trimoxazole

Targeted antimicrobial prophylaxis

Fosfomycin DRUG

see study arms.

Also known as: Monuril

Targeted antimicrobial prophylaxis

Pivmecillinam/augmentin DRUG

see study arms.

Also known as: Selexid, Amoxicillin/clavulanic acid

Targeted antimicrobial prophylaxis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (13)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Bravis

Bergen op Zoom, Netherlands

Location

Amphia Hospital

Breda, Netherlands

Location

Catharina Hospital

Eindhoven, Netherlands

Location

Zuyderland Hospital

Heerlen, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Bravis

Roosendaal, Netherlands

Location

Zuyderland Hospital

Sittard, Netherlands

Location

Elisabeth Tweesteden Hospital

Tilburg, Netherlands

Location

Bernhoven Hospital

Uden, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 37101774 DERIVED

• 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.

  PMID: 36419331 DERIVED

MeSH Terms

Conditions

Infections; Prostatic Neoplasms

Interventions

Ciprofloxacin; Trimethoprim, Sulfamethoxazole Drug Combination; Fosfomycin; Amdinocillin Pivoxil; Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations; Organophosphonates; Organophosphorus Compounds; Amdinocillin; Penicillins; beta-Lactams; Lactams; Clavulanic Acid; Clavulanic Acids; Amoxicillin; Ampicillin; Penicillin G

Study Officials

• Heiman Wertheim, Prof. dr.

  Radboud University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 24, 2017
• Study Start: April 3, 2018
• Primary Completion: September 26, 2021
• Study Completion: September 26, 2021
• Last Updated: May 10, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (13)