Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

Prostate Cancer Clinical Trial

— pro-SWAP  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03228108
• Other study ID #: pro-SWAP104622
• Status: Completed
• Phase: Phase 4
• Start date: April 3, 2018
• Est. completion date: September 26, 2021

Study information

• Verified date: November 2021
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1538
• Est. completion date: September 26, 2021
• Est. primary completion date: September 26, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complication
• Infection
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Ciprofloxacin
see study arms.
• Trimethoprim/Sulfamethoxazole
see study arms.
• Fosfomycin
see study arms.
• Pivmecillinam/augmentin
see study arms.

Locations

Country	Name	City	State
Netherlands	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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any registered clinical infectious complication after prostate biopsy	Urinary tract infection, pyelonephritis, sepsis, fever, acute prostatitis, acute epididymitis	within 7 days post-biopsy
Secondary	Cost of care	Difference of costs between the intervention and the control group	within 30 days after prostate biopsy
Secondary	Positive microbiological results	Urine or blood culture results	within 7 and 30 days after prostate biopsy
Secondary	Any registered clinical infectious complication after prostate biopsy	Urinary tract infection, pyelonephritis, sepsis, fever, acute prostatitis, acute epididymitis	within 7 and 30 days after prostate biopsy
Secondary	Hospitalization after prostate biopsy	Any hospital admission, including ICU admission	within 30 days after prostate biopsy
Secondary	Overall mortality	Mortality of any cause	within 30 days after prostate biopsy
Secondary	Side effects of used antibiotics	All side effects mentioned in the Summary of Product Characteristics (SPC)	within 30 days after prostate biopsy
Secondary	Prevalence of ciprofloxacin-resistant gram negative bacilli in local rectal flora	Assessed through microbiological rectal swab cultures	rectal swabs are taken 14 days before biopsy
Secondary	Overall antibiotic use after prostate biopsy	Number of antibiotic prescriptions	within 30 days after prostate biopsy