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

August 15, 2024 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
728

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Symptomatic UrinaryTract Infection (UTI)
Time Frame: within 30 days after randomization
Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents
within 30 days after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
within 30 days after randomization
Symptomatic cystitis (based on clinical diagnosis)
Time Frame: within 30 days after randomization
Symptomatic cystitis (based on clinical diagnosis)
within 30 days after randomization
Symptomatic epididymitis (based on clinical diagnosis)
Time Frame: within 30 days after randomization
Symptomatic epididymitis (based on clinical diagnosis)
within 30 days after randomization
Symptomatic pyelonephritis (based on clinical diagnosis)
Time Frame: within 30 days after randomization
Symptomatic pyelonephritis (based on clinical diagnosis)
within 30 days after randomization
Symptomatic prostatitis (based on clinical diagnosis)
Time Frame: within 30 days after randomization
Symptomatic prostatitis (based on clinical diagnosis)
within 30 days after randomization
Symptomatic urethritis (based on clinical diagnosis)
Time Frame: within 30 days after randomization
Symptomatic urethritis (based on clinical diagnosis)
within 30 days after randomization
Urosepsis (based on clinical diagnosis)
Time Frame: within 30 days after randomization
Urosepsis (based on clinical diagnosis)
within 30 days after randomization
Prescription of antibiotics (for any reason)
Time Frame: within 30 days after randomization
Prescription of antibiotics (for any reason)
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
Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD)
within 30 days after randomization
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
within 30 days after randomization
Detection of multidrug-resistant bacteria in Urine culture
Time Frame: within 30 days after randomization
Detection of multidrug-resistant bacteria in Urine culture
within 30 days after randomization
Any Clostridium difficile-associated infection
Time Frame: within 30 days after randomization
Any Clostridium difficile-associated infection
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 catheterisation (cumulative sum of days between randomisation and end of catheterisation or day 30)
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 hospital stay (cumulative sum of Hospital days between randomisation and day 30)
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
Duration of intensive care unit stay (cumulative sum of ICU days between randomisation and day 30)
within 30 days after randomization
Re-hospitalisation (within 30 days after randomisation)
Time Frame: within 30 days after randomization
Re-hospitalisation (within 30 days after randomisation)
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 International Prostate Symptom Score (prior to randomisation and at day 30 after randomisation)
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
Change of Quality of life Score (prior to randomisation and at day 30 after randomisation)
within 30 days after randomization
All-cause mortality
Time Frame: within 30 days after randomization
All-cause mortality
within 30 days after randomization
Total adverse events
Time Frame: within 30 days after randomization
Total adverse events
within 30 days after randomization
Total serious adverse events
Time Frame: within 30 days after randomization
Total serious adverse events
within 30 days after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas Widmer, Prof.,MD,Dr., Division of Infectious Diseases and Hospital Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 29, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-0104; me17Widmer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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