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CompletedNCT03633643CITrUSUpdated Aug 16, 2024

Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Vaporisation of the Prostate

A Phase 4 interventional study of oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) and oral applications of Placebo in Antimicrobial Prophylaxis in Prostate Surgery, sponsored by University Hospital, Basel, Switzerland. Completed at 5 sites in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-16.

Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
728
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The optimal duration of antimicrobial prophylaxis (study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole)) in transurethral resection of the prostate and Greenlight Laser vaporisation of the prostate is investigated by comparing a guideline-conform single-dose prophylaxis (intervention) versus usual clinical care (i.e. 3-day prophylaxis; control) for prevention of urinary tract infections.

Read the detailed description

Increasing antimicrobial resistance rates have a substantial impact on morbidity, mortality and healthcare costs and is particularly prevalent among urological patients due to an overuse of antimicrobial agents for therapeutical and prophylactic indications. Transurethral resection of the prostate is one of the most frequently performed urological procedures in Switzerland and a single-dose of antimicrobial prophylaxis is recommended to reduce postoperative urinary tract infections. For photoselective vaporisation of the prostate with the Greenlight Laser, a similar operative alternative, there are currently no international guidelines for antimicrobial prophylaxis.

The optimal duration of antimicrobial prophylaxis in transurethral resection of the prostate and Greenlight Laser vaporisation of the prostate is investigated by comparing a guideline-conform single-dose prophylaxis (intervention) versus usual clinical care (i.e. 3-day prophylaxis; control) for prevention of urinary tract infections.

The study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole) is a routinely used antimicrobial substance recommended in international and in-house guidelines for antimicrobial prophylaxis and treatment of urinary tract infections. Perioperative antimicrobial prophylaxis will be Cotrimoxazole short infusion in both groups. Postoperative study medication packages consists of either five tablets of placebo or five tablets of Cotrimoxazole (Nopil forte®) 800/160mg using licensed product repacked in a new immediate container which is blinded

02

Conditions studied

  • Antimicrobial Prophylaxis in Prostate Surgery

Keywords

  • Greenlight Laser Vaporisation of the Prostate
  • Transurethral resection of the prostate
  • Cotrimoxazole Prophylaxis
03

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Obstructive voiding disorder (e.g. benign prostate hyperplasia, obstructive prostate cancer)
  • Planned Transurethral resection of the prostate (TURP) or Greenlight Laser (GL)

Exclusion criteria

Exclusion Criteria:

  • Evidence for (catheter associated-) UTI, with or without antibiotic treatment in the last 7 days prior to randomisation.
  • Any evidence of a history of positive urine culture (cfu ³105/ml in midstream-urine with no more than two species) and resistance to TMP/SMX in the last 7 days prior to randomisation.
  • Known contraindication against study drugs according to the Swissmedic package leaflet (e.g. known liver dysfunction, renal insufficiency; patients with glomerular filtration rate (calculated by the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<30ml/min or dialysis patients will be excluded).
  • Antibiotic treatment for any reason within 7 days prior to randomisation
  • Indication for Antibiotic prophylaxis (AP) for other reasons (e.g. endocarditis prophylaxis, transplanted patients under systemic immunosuppression).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
728 participants (actual)

Study arms

  • Placebo comparator
    Group A

    Single-dose Trimethoprim (TMP)/sulfamethoxazole (SMX, i.e. Cotrimoxazole) perioperative as two ampoules of TMP/SMX 400/80 mg (Bactrim Inf Konz®) solved in 250 ml sodium chloride short infusion followed by five oral applications of placebo (lactose tablet; Fagron Gesellschaft mit beschränkter Haftung (GmbH) \& Co.KG) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

    Drug: oral applications of Placebo

  • Active comparator
    Group B

    3-day application with TMP/SMX (i.e. Cotrimoxazole): Preoperatively as two ampoules of TMP/SMX 400/80mg (Bactrim Inf Konz®) solved in 250 ml sodium chloride short infusion, followed by five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

    Drug: oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)

Interventions

  • Drugoral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)

    five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

  • Drugoral applications of Placebo

    five oral applications of Placebo at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.

06

What researchers measure

Primary outcomes

  1. Symptomatic UrinaryTract Infection (UTI)

    Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents

    Time frame: within 30 days after randomization

Secondary outcomes

  1. Symptomatic UTI by measured bacteriuria

    measured bacteriuria of ≥105 cfu/ml treated with antimicrobial agents (key secondary outcome)

    Time frame: within 30 days after randomization

  2. Symptomatic cystitis (based on clinical diagnosis)

    Symptomatic cystitis (based on clinical diagnosis)

    Time frame: within 30 days after randomization

  3. Symptomatic epididymitis (based on clinical diagnosis)

    Symptomatic epididymitis (based on clinical diagnosis)

    Time frame: within 30 days after randomization

  4. Symptomatic pyelonephritis (based on clinical diagnosis)

    Symptomatic pyelonephritis (based on clinical diagnosis)

    Time frame: within 30 days after randomization

  5. Symptomatic prostatitis (based on clinical diagnosis)

    Symptomatic prostatitis (based on clinical diagnosis)

    Time frame: within 30 days after randomization

  6. Symptomatic urethritis (based on clinical diagnosis)

    Symptomatic urethritis (based on clinical diagnosis)

    Time frame: within 30 days after randomization

  7. Urosepsis (based on clinical diagnosis)

    Urosepsis (based on clinical diagnosis)

    Time frame: within 30 days after randomization

  8. Prescription of antibiotics (for any reason)

    Prescription of antibiotics (for any reason)

    Time frame: within 30 days after randomization

  9. Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) day 30)

    Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD)

    Time frame: within 30 days after randomization

  10. Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents

    Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents

    Time frame: within 30 days after randomization

  11. Detection of multidrug-resistant bacteria in Urine culture

    Detection of multidrug-resistant bacteria in Urine culture

    Time frame: within 30 days after randomization

  12. Any Clostridium difficile-associated infection

    Any Clostridium difficile-associated infection

    Time frame: within 30 days after randomization

  13. Duration of catheterisation (cumulative sum of days between randomisation and end of catheterisation or day 30)

    Duration of catheterisation (cumulative sum of days between randomisation and end of catheterisation or day 30)

    Time frame: within 30 days after randomization

  14. Duration of hospital stay (cumulative sum of Hospital days between randomisation and day 30)

    Duration of hospital stay (cumulative sum of Hospital days between randomisation and day 30)

    Time frame: within 30 days after randomization

  15. Duration of intensive care unit (ICU) stay (cumulative sum of ICU days between randomisation and day 30)

    Duration of intensive care unit stay (cumulative sum of ICU days between randomisation and day 30)

    Time frame: within 30 days after randomization

  16. Re-hospitalisation (within 30 days after randomisation)

    Re-hospitalisation (within 30 days after randomisation)

    Time frame: within 30 days after randomization

  17. Change of International Prostate Symptom Score (prior to randomisation and at day 30 after randomisation)

    Change of International Prostate Symptom Score (prior to randomisation and at day 30 after randomisation)

    Time frame: within 30 days after randomization

  18. Change of Quality of life Score (prior to randomisation and at day 30 after randomisation)

    Change of Quality of life Score (prior to randomisation and at day 30 after randomisation)

    Time frame: within 30 days after randomization

  19. All-cause mortality

    All-cause mortality

    Time frame: within 30 days after randomization

  20. Total adverse events

    Total adverse events

    Time frame: within 30 days after randomization

  21. Total serious adverse events

    Total serious adverse events

    Time frame: within 30 days after randomization

07

Study locations

5 sites
  • St. Claraspital, Department of Urology
    Basel, Basel Stadt 4058, Switzerland
  • Kantonsspital Aarau, Department of Urology
    Aarau, 5001, Switzerland
  • University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
    Basel, 4031, Switzerland
  • Kantonsspital Baselland, Department of Urology
    Liestal, 4410, Switzerland
  • University Hospital Zurich, Department of Urology
    Zürich, 8091, Switzerland
08

References and documents

Publications

  • Speich B, Bausch K, Roth JA, Hemkens LG, Ewald H, Vogt DR, Bruni N, Deuster S, Seifert HH, Widmer AF. Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial). Trials. 2019 Feb 19;20(1):142. doi: 10.1186/s13063-019-3237-3. PubMed 30782183 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03633643
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation
Responsible party
Sponsor
First posted
Aug 16, 2018
Start date
Oct 29, 2018
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022
Last update
Aug 16, 2024

Study contacts

Andreas Widmer, Prof.,MD,Dr.
principal investigator · Division of Infectious Diseases and Hospital Epidemiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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