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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

English 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
Applicant Seifert Hans-Helge
Number 177492
Funding scheme NRP 72 Antimicrobial Resistance
Research institution Abteilung für Infektiologie Institut für klinische Epidemiologie Universitätsspital Basel
Institution of higher education University of Basel - BS
Main discipline Surgery
Start/End 01.04.2018 - 31.03.2023
Approved amount 550'000.00
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All Disciplines (2)

Discipline
Surgery
Internal Medicine

Keywords (6)

transurethral resection of the prostate; antimicrobial resistance; emergence of antimicrobial resistance; antimicrobial prophylaxis; greenlight laser of the prostate; urinary tract infections

Lay Summary (German)

Lead
In der Urologie werden vielzählige therapeutische und prophylaktische Antibiosen eingesetzt, während die Raten an antibiotikaresistenten Keimen steigen. Wir vergleichen bei urologischen Operationen eine antibiotische Einzeldosisprophylaxe mit der aktuellen klinischen Praxis von drei Tagen.
Lay summary

Porträt/Projektbeschrieb

In der ersten Phase wird die tatsächliche klinische Praxis von antibiotischen Prophylaxen während transurethralen Resektionen und Greenlight Laservaporisationen der Prostata, häufigen urologischen Operationen, an fünf Studienzentren retrospektiv untersucht.

In der zweiten Phase werden prospektiv Patienten zur transurethralen Resektion und Laservaporisation der Prostata einer leitlinienkonformen Einzeldosisgruppe einer antibiotischen Prophylaxe und einer Drei-Tage-Prophylaxe Gruppe zugeteilt. An fünf Studienzentren werden postoperative Infekte, antibiotikaassoziierten Nebenwirkungen und die Entwicklung von antimikrobiellen Resistenzen untersucht.

Hintergrund/Ausgangslage

In urologischen Kliniken werden höhere Raten an antibiotikaresistenten Keimen als in anderen Disziplinen gefunden, bedingt durch den enormen Einsatz von Antibiotika. Etwa 10,000 Männer erhalten in der Schweiz jährlich eine transurethralen Resektion der Prostata; die Laservaporisation der Prostata hat sich als Alternative für Patienten unter blutverdünnender Therapie etabliert. Internationale Leitlinien empfehlen eine Einzeldosis einer antimikrobiellen Prophylaxe zur Vermeidung von Infektkomplikationen. Die klinische Praxis weicht jedoch stark davon ab.


Ziele

Unsere Untersuchungen werden dazu beitragen, den Antibiotikaeinsatz auf ein notwendiges Minimum zu reduzieren, ohne dabei die Patientensicherheit zu gefährden und dabei zusätzlich die Entwicklung antimikrobieller Resistenzen zu vermindern.

Bedeutung/möglicher Nutzen

Eine einzelne Dosis für die Antibiotikaprophylaxe statt mehrere Tage führt zu einer geringeren Belastung für den Patienten, weniger Nebenwirkungen und einem geringeren Risiko der Antibiotika-Resistenzentwicklung, vorausgesetzt, dass die Infektionshäufigkeit vergleichbar bleibt. Diese vergleichbar einfache Verbesserung kommt einer hohen Anzahl von Patienten zugute und erlaubt bewährte Substanzen auch in Zukunft in der Prophylaxe und Therapie verwenden zu können.
Direct link to Lay Summary Last update: 04.06.2018

Responsible applicant and co-applicants

Employees

Project partner

Publications

Publication
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)
Speich Benjamin, Bausch Kathrin, Roth Jan A., Hemkens Lars G., Ewald Hannah, Vogt Deborah R., Bruni Nicole, Deuster Stefanie, Seifert Hans-H., Widmer Andreas F. (2019), 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), in Trials, 20(1), 142-142.
High incidence of urinary tract infections after photoselective laser vaporisation of the prostate: a risk factor analysis of 665 patients
Bausch Kathrin, MotzerJ, RothJA, DangelM, SeifertHH, WidmerAF (2019), High incidence of urinary tract infections after photoselective laser vaporisation of the prostate: a risk factor analysis of 665 patients, in World Journal of Urology, ePub.

Collaboration

Group / person Country
Types of collaboration
Austrian Association of Urology Austria (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Swiss Association of Urology Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Swissnoso Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
World Congress of Endourology - Abu Dhabi Talk given at a conference High incidence of urinary tract infections after photoselective laser vaporisation of the prostate: a risk factor analysis of 665 patients 30.10.2019 Abu Dhabi, United Arab Emirates Seifert Hans-Helge;
SGU 2019 Zürich Talk given at a conference High incidence of urinary tract infections after photoselective laser vaporisation of the prostate: a risk factor analysis of 665 patients 04.09.2019 Zürich, Switzerland Widmer Andreas; Bausch Kathrin; Seifert Hans-Helge;
Kongress der deutschen Gesellschaft für Urologie Poster 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 26.09.2018 Dresden, Germany Widmer Andreas; Bausch Kathrin; Seifert Hans-Helge;


Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
SIGUP Meeting Olten - Eingeladener Referent zur antibiotischen Prophylaxe in Urologie plus CITrUS Studie Talk 05.04.2019 Olten, Switzerland Bausch Kathrin;


Communication with the public

Communication Title Media Place Year
Talks/events/exhibitions Single-Dose Versus 3-Day Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Va German-speaking Switzerland 2018

Abstract

The worldwide increase of antimicrobial resistances has gained international attention and has been labelled by the World Health Organisation as top public health priority. Today, in urological out- and inpatients, multidrug-resistance among main uropathogens such as Escherichia coli is increasing rapidly - which can, at least partly, be explained by the well-characterised extended use and over-prescription of antibiotics in daily urological practice, especially for antibiotic prophylaxis (AP) in standard urological procedures. A prolonged course of AP decreases the rate of bacteriuria at the expense of higher rates of adverse drug events, Clostridium difficile-associated infections and consecutive antimicrobial resistances.Transurethral resection of the prostate (TURP) is one of the most frequently performed urological procedures, which is conducted in almost 10,000 men annually in Switzerland. However, photoselective vaporisation with the Greenlight Laser (GL) has become an important alternative to TURP, particularly in patients receiving anticoagulation therapy. Generally, urine is sterile, but TURP and GL are performed in an elderly population, where asymptomatic bacteriuria is highly prevalent; therefore, TURP belongs to the category “clean-contaminated” according to the World Health Organisation and consequently, routine AP in TURP is considered as a standard of care. The European Association of Urology and our in-house guidelines recommend routine AP in TURP to decrease the incidence of bacteriuria, bacteraemia, and urinary tract infections (UTIs). But currently, there are no randomised controlled trials and guidelines for AP in patients undergoing GL. In addition, most of the studies for AP in TURP were performed more than twenty years ago - with still a large gap being present between actual clinical practice of AP in TURP and evidence-based guidelines especially in terms of duration of AP. Therefore, we aim to compare the effectiveness of the current clinical practice (usual care with prolonged AP) to guideline-conform single-shot AP with trimethoprim/sulfamethoxazole in patients undergoing TURP and GL. For this purpose, we will conduct a multicentre pragmatic randomised controlled trial analysing the non-inferiority of a single-dose AP on the primary outcome measure of postoperative UTI and urosepsis within 30 days after TURP and GL. The results of this study will help to elaborate guidelines on AP and antimicrobial stewardship in TURP and GL.
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