Evidence map›Paper›PMID 30782183›Full record

ArticleTrials2019

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).

Benjamin Speich, Kathrin Bausch, Jan A Roth, Lars G Hemkens, Hannah Ewald, Deborah R Vogt, Nicole Bruni, Stefanie Deuster, Hans-H Seifert, Andreas F Widmer

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03633643 (Single-Dose Versus 3-Day Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Vaporisation of the Prostate), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03633643 phase4completednot on this map

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

TypeinterventionalSponsorUniversity Hospital, Basel, SwitzerlandRan2018 to 2022Enrolled728ConditionsAntimicrobial Prophylaxis in Prostate SurgeryArmsoral applications of TMP/SMX 800/160 mg (Nopil forte® tablets), oral applications of Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Benjamin SpeichBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Kathrin BauschDepartment of Urology, University Hospital Basel, University of Basel, Basel, Switzerland.
Jan A RothBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Lars G HemkensBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Hannah EwaldBasel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Deborah R VogtClinical Trial Unit, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Nicole BruniClinical Trial Unit, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
Stefanie DeusterHospital Pharmacy, University Hospital Basel, Basel, Switzerland.
Hans-H SeifertDepartment of Urology, University Hospital Basel, University of Basel, Basel, Switzerland.
Andreas F WidmerDivision of Infectious Diseases and 721 Hospital Epidemiology, University Hospital Basel, University of Basel, Petersgraben, 4031, Basel, Switzerland. andreas.widmer@usb.ch.

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung NFP 72 - Grant No SNF407240_177492
6 · The paper itself

Abstract

backgroundTransurethral resection of the prostate (TURP) and Greenlight laser vaporisation (GL) of the prostate are frequently performed urological procedures. For TURP, a single-dose antimicrobial prophylaxis (AP) is recommended to reduce postoperative urinary tract infections. So far, no international recommendations for AP have been established for GL. In a survey-based study in Switzerland, Germany and Austria, urologists reported routinely extending AP primarily for 3 days after both interventions. We therefore aim to determine whether single-dose AP with cotrimoxazole is non-inferior to 3-day AP with cotrimoxazole in patients undergoing TURP or GL of the prostate. METHODS/

designWe will conduct an investigator-initiated, multicentre, randomised controlled trial. We plan to assess the non-inferiority of single-dose AP compared to 3-day AP. The primary outcome is the occurrence of clinically diagnosed symptomatic urinary tract infections which are treated with antimicrobial agents within 30 days after randomisation. The vast majority of collected outcomes will be assessed from routinely collected data. The sample size was estimated to be able to show the non-inferiority of single-dose AP compared to 3-day AP with at least 80% power (1 - β = 0.8) at a significance level of α = 5%, applying a 1:1 randomisation scheme. The non-inferiority margin was determined in order to preserve 70% of the effect of usual care on the primary outcome. For an assumed event rate of 9% in both treatment arms, this resulted in a non-inferiority margin of 4.4% (i.e. 13.4% to 9%). To prove non-inferiority, a total of 1574 patients should be recruited, in order to have 1416 evaluable patients. The study is supported by the Swiss National Science Foundation. DISCUSSION: For AP in TURP and GL, there is a large gap between usual clinical practice and evidence-based guidelines. If single-dose AP proves non-inferior to prolonged AP, our study findings may help to reduce the duration of AP in daily routine-potentially reducing the risk of emerging resistance and complications related to AP.

trial registrationClinicaltrials.gov, NCT03633643 . Registered 16 August 2018.

Indexed as

Anti-Bacterial AgentsAntibiotic ProphylaxisAnti-Infective Agents, UrinaryDrug Administration ScheduleEquivalence Trials as TopicHumansLaser TherapyMaleMulticenter Studies as TopicProstatic HyperplasiaProstatic NeoplasmsSwitzerlandTime FactorsTransurethral Resection of ProstateTreatment OutcomeTrimethoprim, Sulfamethoxazole Drug CombinationAnti-Bacterial AgentsAnti-Infective Agents, UrinaryTrimethoprim, Sulfamethoxazole Drug CombinationAntibiotic prophylaxisGreenlight laser vaporisationRandomised controlled trialTransurethral resection of prostateUrinary tract infection

Identifiers

PMID30782183
PMCPMC6381623

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.