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

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ClinicalTrials.gov Identifier: NCT03633643
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : December 26, 2019
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment Phase
Antimicrobial Prophylaxis in Prostate Surgery Drug: oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) Drug: oral applications of Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1574 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-dose application of Cotrimoxazole compared to a 3-day application of Cotrimoxazole
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-Dose Versus 3-Day Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Vaporisation of the Prostate: A Pragmatic, Multicentre Randomised Placebo Controlled Non-Inferiority Trial
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Arm Intervention/treatment
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
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.

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)

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.





Primary Outcome Measures :
  1. Symptomatic UrinaryTract Infection (UTI) [ Time Frame: within 30 days after randomization ]
    Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents


Secondary Outcome Measures :
  1. Symptomatic UTI by measured bacteriuria [ Time Frame: within 30 days after randomization ]
    measured bacteriuria of ≥105 cfu/ml treated with antimicrobial agents (key secondary outcome)

  2. Symptomatic cystitis (based on clinical diagnosis) [ Time Frame: within 30 days after randomization ]
    Symptomatic cystitis (based on clinical diagnosis)

  3. Symptomatic epididymitis (based on clinical diagnosis) [ Time Frame: within 30 days after randomization ]
    Symptomatic epididymitis (based on clinical diagnosis)

  4. Symptomatic pyelonephritis (based on clinical diagnosis) [ Time Frame: within 30 days after randomization ]
    Symptomatic pyelonephritis (based on clinical diagnosis)

  5. Symptomatic prostatitis (based on clinical diagnosis) [ Time Frame: within 30 days after randomization ]
    Symptomatic prostatitis (based on clinical diagnosis)

  6. Symptomatic urethritis (based on clinical diagnosis) [ Time Frame: within 30 days after randomization ]
    Symptomatic urethritis (based on clinical diagnosis)

  7. Urosepsis (based on clinical diagnosis) [ Time Frame: within 30 days after randomization ]
    Urosepsis (based on clinical diagnosis)

  8. Prescription of antibiotics (for any reason) [ Time Frame: within 30 days after randomization ]
    Prescription of antibiotics (for any reason)

  9. Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) day 30) [ Time Frame: within 30 days after randomization ]
    Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD)

  10. Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents [ Time Frame: within 30 days after randomization ]
    Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents

  11. Detection of multidrug-resistant bacteria in Urine culture [ Time Frame: within 30 days after randomization ]
    Detection of multidrug-resistant bacteria in Urine culture

  12. Any Clostridium difficile-associated infection [ Time Frame: within 30 days after randomization ]
    Any Clostridium difficile-associated infection

  13. Duration of catheterisation (cumulative sum of days between randomisation and end of catheterisation or day 30) [ Time Frame: within 30 days after randomization ]
    Duration of catheterisation (cumulative sum of days between randomisation and end of catheterisation or day 30)

  14. Duration of hospital stay (cumulative sum of Hospital days between randomisation and day 30) [ Time Frame: within 30 days after randomization ]
    Duration of hospital stay (cumulative sum of Hospital days between randomisation and day 30)

  15. Duration of intensive care unit (ICU) stay (cumulative sum of ICU days between randomisation and day 30) [ Time Frame: within 30 days after randomization ]
    Duration of intensive care unit stay (cumulative sum of ICU days between randomisation and day 30)

  16. Re-hospitalisation (within 30 days after randomisation) [ Time Frame: within 30 days after randomization ]
    Re-hospitalisation (within 30 days after randomisation)

  17. Change of International Prostate Symptom Score (prior to randomisation and at day 30 after randomisation) [ Time Frame: within 30 days after randomization ]
    Change of International Prostate Symptom Score (prior to randomisation and at day 30 after randomisation)

  18. Change of Quality of life Score (prior to randomisation and at day 30 after randomisation) [ Time Frame: within 30 days after randomization ]
    Change of Quality of life Score (prior to randomisation and at day 30 after randomisation)

  19. All-cause mortality [ Time Frame: within 30 days after randomization ]
    All-cause mortality

  20. Total adverse events [ Time Frame: within 30 days after randomization ]
    Total adverse events

  21. Total serious adverse events [ Time Frame: within 30 days after randomization ]
    Total serious adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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).

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): NCT03633643


Contacts
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Contact: Andreas Widmer, Prof.,MD,Dr. +41 61 265 38 51 andreas.widmer@usb.ch
Contact: Hans-Helge Seifert, PD,MD,Dr. +41 61 265 38 51 hans-helge.seifert@usb.ch

Locations
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Switzerland
St. Claraspital, Department of Urology Recruiting
Basel, Basel Stadt, Switzerland, 4058
Contact: Peter Ardelt, Dr. med    +41 61 685 85 23      
Kantonsspital Aarau, Department of Urology Recruiting
Aarau, Switzerland, 5001
Contact: Maciej Kwiatkowski, Dr. med    +41 62 838 47 47      
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology Recruiting
Basel, Switzerland, 4031
Contact: Andreas Widmer, Prof.Dr.med    +41 61 265 38 51    andreas.widmer@usb.ch   
Contact: Kathrin Bausch, Dr.med       kathrin.bausch@usb.ch   
Kantonsspital Baselland, Department of Urology Recruiting
Liestal, Switzerland, 4410
Contact: Svetozar Subotic, Dr. med    +41 61 925 21 72      
University Hospital Zurich, Department of Urology Not yet recruiting
Zürich, Switzerland, 8091
Contact: Thomas Hermanns, PD Dr. med    +41 44 255 54 40      
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Investigators
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Principal Investigator: Andreas Widmer, Prof.,MD,Dr. Division of Infectious Diseases and Hospital Epidemiology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03633643    
Other Study ID Numbers: 2018-0104; me17Widmer
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Greenlight Laser Vaporisation of the Prostate
Transurethral resection of the prostate
Cotrimoxazole Prophylaxis