Antimicrobial Prophylaxis in Prostate SurgeryPhase 4CITrUSNCT03633643
Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Vaporisation of the Prostate
A Phase 4 study testing oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) in people with Antimicrobial Prophylaxis in Prostate Surgery, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Antimicrobial Prophylaxis in Prostate Surgery
- What is being tested?
- oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 728 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 29 Oct 2018to 31 Oct 2022
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstructive voiding disorder (e.g. benign prostate hyperplasia, obstructive prostate cancer)
- Planned Transurethral resection of the prostate (TURP) or Greenlight Laser (GL)
Who cannot join
- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
Kantonsspital Aarau, Department of Urology
Aarau, 5001
St. Claraspital, Department of Urology
Basel, Canton of Basel-City, 4058
University Hospital Basel, Division of Infectious Diseases and Hospital Epidemiology
Basel, 4031
Kantonsspital Baselland, Department of Urology
Liestal, 4410
University Hospital Zurich, Department of Urology
Zurich, 8091
About this study
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
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
- Being tested
- oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets), oral applications of Placebo
- Keywords
- Greenlight Laser Vaporisation of the Prostate, Transurethral resection of the prostate, Cotrimoxazole Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)Drug
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.
oral applications of PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | 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. Receives: Drug: oral applications of Placebo |
| Group B | Active comparator | 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. Receives: Drug: oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic UrinaryTract Infection (UTI)
Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents
Measured: within 30 days after randomization
Secondary outcomes (21)
Symptomatic UTI by measured bacteriuria
measured bacteriuria of ≥105 cfu/ml treated with antimicrobial agents (key secondary outcome)
Measured: within 30 days after randomization
Symptomatic cystitis (based on clinical diagnosis)
Symptomatic cystitis (based on clinical diagnosis)
Measured: within 30 days after randomization
Symptomatic epididymitis (based on clinical diagnosis)
Symptomatic epididymitis (based on clinical diagnosis)
Measured: within 30 days after randomization
Symptomatic pyelonephritis (based on clinical diagnosis)
Symptomatic pyelonephritis (based on clinical diagnosis)
Measured: within 30 days after randomization
Symptomatic prostatitis (based on clinical diagnosis)
Symptomatic prostatitis (based on clinical diagnosis)
Measured: within 30 days after randomization
Symptomatic urethritis (based on clinical diagnosis)
Symptomatic urethritis (based on clinical diagnosis)
Measured: within 30 days after randomization
Urosepsis (based on clinical diagnosis)
Urosepsis (based on clinical diagnosis)
Measured: within 30 days after randomization
Prescription of antibiotics (for any reason)
Prescription of antibiotics (for any reason)
Measured: within 30 days after randomization
Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) day 30)
Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD)
Measured: within 30 days after randomization
Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents
Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents
Measured: within 30 days after randomization
Detection of multidrug-resistant bacteria in Urine culture
Detection of multidrug-resistant bacteria in Urine culture
Measured: within 30 days after randomization
Any Clostridium difficile-associated infection
Any Clostridium difficile-associated infection
Measured: within 30 days after randomization
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)
Measured: within 30 days after randomization
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)
Measured: within 30 days after randomization
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)
Measured: within 30 days after randomization
Re-hospitalisation (within 30 days after randomisation)
Re-hospitalisation (within 30 days after randomisation)
Measured: within 30 days after randomization
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)
Measured: within 30 days after randomization
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)
Measured: within 30 days after randomization
All-cause mortality
All-cause mortality
Measured: within 30 days after randomization
Total adverse events
Total adverse events
Measured: within 30 days after randomization
Total serious adverse events
Total serious adverse events
Measured: within 30 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start29 Oct 2018
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial Prophylaxis in Prostate SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-dose application of Cotrimoxazole compared to a 3-day application of Cotrimoxazole
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Andreas Widmer, Prof.,MD,Dr., Principal investigator, Division of Infectious Diseases and Hospital Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633643
- Sponsor's protocol ID
- 2018-0104; me17Widmer
- Acronym
- CITrUS
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2018
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03633643
- Acronym / sponsor ID
- CITrUS / 2018-0104; me17Widmer
- Keywords
- Greenlight Laser Vaporisation of the Prostate, Transurethral resection of the prostate, Cotrimoxazole Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single-dose application of Cotrimoxazole compared to a 3-day application of Cotrimoxazole
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Drug: oral applications of PlaceboSingle-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. |
| Group B | Active comparator | Drug: oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obstructive voiding disorder (e.g. benign prostate hyperplasia, obstructive prostate cancer)
- Planned Transurethral resection of the prostate (TURP) or Greenlight Laser (GL)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group B |
| oral applications of Placebofive 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. | Drug | Group A |
Primary outcome
Symptomatic UrinaryTract Infection (UTI)
Time frame: within 30 days after randomization
Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents
21 secondary outcomes
Symptomatic UTI by measured bacteriuria
Time frame: within 30 days after randomization
Symptomatic cystitis (based on clinical diagnosis)
Time frame: within 30 days after randomization
Symptomatic epididymitis (based on clinical diagnosis)
Time frame: within 30 days after randomization
Symptomatic pyelonephritis (based on clinical diagnosis)
Time frame: within 30 days after randomization
Symptomatic prostatitis (based on clinical diagnosis)
Time frame: within 30 days after randomization
Symptomatic urethritis (based on clinical diagnosis)
Time frame: within 30 days after randomization
Urosepsis (based on clinical diagnosis)
Time frame: within 30 days after randomization
Prescription of antibiotics (for any reason)
Time frame: within 30 days after randomization
Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) day 30)
Time frame: within 30 days after randomization
Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents
Time frame: within 30 days after randomization
Detection of multidrug-resistant bacteria in Urine culture
Time frame: within 30 days after randomization
Any Clostridium difficile-associated infection
Time frame: within 30 days after randomization
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 hospital stay (cumulative sum of Hospital days between randomisation and day 30)
Time frame: within 30 days after randomization
Duration of intensive care unit (ICU) stay (cumulative sum of ICU days between randomisation and day 30)
Time frame: within 30 days after randomization
Re-hospitalisation (within 30 days after randomisation)
Time frame: within 30 days after randomization
Change of International Prostate Symptom 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)
Time frame: within 30 days after randomization
All-cause mortality
Time frame: within 30 days after randomization
Total adverse events
Time frame: within 30 days after randomization
Total serious adverse events
Time frame: within 30 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Derived from this study: PubMed 30782183Speich 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Widmer, Prof.,MD,Dr. principal investigator
Division of Infectious Diseases and Hospital Epidemiology
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) in people with Antimicrobial Prophylaxis in Prostate Surgery, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
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 5 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 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Symptomatic UrinaryTract Infection (UTI) (time frame: within 30 days after randomization). 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 NCT03633643, which also lists 1 linked publication.
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 16 Aug 2024.