Antimicrobial Prophylaxis in Prostate Surgery Clinical Trial
— CITrUSOfficial 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
| Verified date | January 2024 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 1574 |
| Est. completion date | May 31, 2024 |
| Est. primary completion date | May 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Kantonsspital Aarau, Department of Urology | Aarau | |
| Switzerland | St. Claraspital, Department of Urology | Basel | Basel Stadt |
| Switzerland | University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology | Basel | |
| Switzerland | Kantonsspital Baselland, Department of Urology | Liestal | |
| Switzerland | University Hospital Zurich, Department of Urology | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland | Swiss National Science Foundation |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Symptomatic UrinaryTract Infection (UTI) | Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents | within 30 days after randomization | |
| Secondary | Symptomatic UTI by measured bacteriuria | measured bacteriuria of =105 cfu/ml treated with antimicrobial agents (key secondary outcome) | within 30 days after randomization | |
| Secondary | Symptomatic cystitis (based on clinical diagnosis) | Symptomatic cystitis (based on clinical diagnosis) | within 30 days after randomization | |
| Secondary | Symptomatic epididymitis (based on clinical diagnosis) | Symptomatic epididymitis (based on clinical diagnosis) | within 30 days after randomization | |
| Secondary | Symptomatic pyelonephritis (based on clinical diagnosis) | Symptomatic pyelonephritis (based on clinical diagnosis) | within 30 days after randomization | |
| Secondary | Symptomatic prostatitis (based on clinical diagnosis) | Symptomatic prostatitis (based on clinical diagnosis) | within 30 days after randomization | |
| Secondary | Symptomatic urethritis (based on clinical diagnosis) | Symptomatic urethritis (based on clinical diagnosis) | within 30 days after randomization | |
| Secondary | Urosepsis (based on clinical diagnosis) | Urosepsis (based on clinical diagnosis) | within 30 days after randomization | |
| Secondary | Prescription of antibiotics (for any reason) | Prescription of antibiotics (for any reason) | within 30 days after randomization | |
| Secondary | Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) day 30) | Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) | within 30 days after randomization | |
| Secondary | Asymptomatic bacteriuria of =105 cfu/ml treated with antimicrobial agents | Asymptomatic bacteriuria of =105 cfu/ml treated with antimicrobial agents | within 30 days after randomization | |
| Secondary | Detection of multidrug-resistant bacteria in Urine culture | Detection of multidrug-resistant bacteria in Urine culture | within 30 days after randomization | |
| Secondary | Any Clostridium difficile-associated infection | Any Clostridium difficile-associated infection | within 30 days after randomization | |
| Secondary | 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) | within 30 days after randomization | |
| Secondary | 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) | within 30 days after randomization | |
| Secondary | 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) | within 30 days after randomization | |
| Secondary | Re-hospitalisation (within 30 days after randomisation) | Re-hospitalisation (within 30 days after randomisation) | within 30 days after randomization | |
| Secondary | 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) | within 30 days after randomization | |
| Secondary | 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) | within 30 days after randomization | |
| Secondary | All-cause mortality | All-cause mortality | within 30 days after randomization | |
| Secondary | Total adverse events | Total adverse events | within 30 days after randomization | |
| Secondary | Total serious adverse events | Total serious adverse events | within 30 days after randomization |