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ComplicationPhase 4pro-SWAPNCT03228108

Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy.

A Phase 4 study testing Ciprofloxacin, Trimethoprim/Sulfamethoxazole and Fosfomycin in people with Complication and Infection, run by Radboud University Medical Center at 13 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years, men only
Conditions the study is for
Complication, Infection, Prostate Cancer
What is being tested?
Ciprofloxacin, Trimethoprim/Sulfamethoxazole and Fosfomycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,538 participants
Where
13 sitesNetherlands
Study dates
3 Apr 2018to 26 Sep 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Netherlands13 sites

  • Jeroen Bosch Hospital

    's-Hertogenbosch

  • Rijnstate

    Arnhem

  • Bravis

    Bergen op Zoom

  • Amphia Hospital

    Breda

  • Catharina Hospital

    Eindhoven

  • Zuyderland Hospital

    Heerlen

  • Canisius Wilhelmina Hospital

    Nijmegen

  • Radboud University Medical Center

    Nijmegen

  • Bravis

    Roosendaal

  • Zuyderland Hospital

    Sittard

  • Elisabeth Tweesteden Hospital

    Tilburg

  • Bernhoven Hospital

    Uden

  • Isala

    Zwolle

Other trials in Netherlands

About this study

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.

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.

Read the 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.

Being tested
Ciprofloxacin, Trimethoprim/Sulfamethoxazole, Fosfomycin, Pivmecillinam/augmentin
Keywords
Culture-guided, Targeted prophylaxis, Prostate biopsy, Antibiotic prophylaxis
Medical subject headings
Infections, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiprofloxacinDrug

    Also called Ciproxin

    see study arms.

  • Trimethoprim/SulfamethoxazoleDrug

    Also called Co-trimoxazole

    see study arms.

  • FosfomycinDrug

    Also called Monuril

    see study arms.

  • Pivmecillinam/augmentinDrug

    Also called Selexid, Amoxicillin/clavulanic acid

    see study arms.

Study groups in NCT03228108
Study groupRoleWhat they receive
Targeted antimicrobial prophylaxisExperimentalMen 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.
Receives: Drug: Ciprofloxacin; Drug: Trimethoprim/Sulfamethoxazole; Drug: Fosfomycin; Drug: Pivmecillinam/augmentin
Routine empirical prophylaxisActive comparatorCiprofloxacin 500 mg orally 2 hours before and 12 hours after transrectal prostate biopsy.
Receives: Drug: Ciprofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any registered clinical infectious complication after prostate biopsy

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

    Measured: within 7 days post-biopsy

Secondary outcomes (8)

  1. Cost of care

    Difference of costs between the intervention and the control group

    Measured: within 30 days after prostate biopsy

  2. Positive microbiological results

    Urine or blood culture results

    Measured: within 7 and 30 days after prostate biopsy

  3. Any registered clinical infectious complication after prostate biopsy

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

    Measured: within 7 and 30 days after prostate biopsy

  4. Hospitalization after prostate biopsy

    Any hospital admission, including ICU admission

    Measured: within 30 days after prostate biopsy

  5. Overall mortality

    Mortality of any cause

    Measured: within 30 days after prostate biopsy

  6. Side effects of used antibiotics

    All side effects mentioned in the Summary of Product Characteristics (SPC)

    Measured: within 30 days after prostate biopsy

  7. Prevalence of ciprofloxacin-resistant gram negative bacilli in local rectal flora

    Assessed through microbiological rectal swab cultures

    Measured: rectal swabs are taken 14 days before biopsy

  8. Overall antibiotic use after prostate biopsy

    Number of antibiotic prescriptions

    Measured: within 30 days after prostate biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start3 Apr 2018
  3. Primary completion26 Sep 2021
  4. Study completion26 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,538 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03228108
Sponsor's protocol ID
pro-SWAP104622
Acronym
pro-SWAP
Status last verified
Nov 2021
First submitted
18 Jul 2017
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37101774

  • 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.

    PubMed 36419331

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ciprofloxacin, Trimethoprim/Sulfamethoxazole and Fosfomycin in people with Complication and Infection, run by Radboud University Medical Center at 13 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any registered clinical infectious complication after prostate biopsy (time frame: within 7 days post-biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03228108, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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