Brief description of trial (Data source: BASEC)
Diese Studie läuft bereits an 5 internationalen Zentren. In der Schweiz wird die Studie in der Urologie des Universitätsspitals Basel durchgeführt. Nach der Zustimmung der Teilnahme werden die Patienten dem Zufallsprinzip folgend entweder in die Gruppe "A=Prophylaxe" oder Gruppe "B=Placebo" eingeteilt. Beide Gaben erfolgen als einmalige orale Gabe kurz vor der Operation. Damit für alle Patienten eine gleichwertige Behandlung garantiert ist, wissen weder Patient noch Ärzte, welche Gruppenzuteilung erfolgt ist. In vielen Ländern wird bereits gemäss internationaler Empfehlungen auf eine solche Prophylaxe verzichtet, in anderen Ländern wird eine solche Prophylaxe noch empfohlen. Nach der Operation werden Harnwegsinfekte in den ersten beiden Wochen nach der extrakorporalen Stosswellentherapie untersucht.
Health conditions investigated(Data source: BASEC)
Die Studie untersucht eine Gabe eines Antibiotikums (=Prophylaxe) gegenüber keinem Wirkstoff (=Placebo) bei der Stosswellentherapie von Harnsteinen.
Health conditions
(Data source: WHO)
Ureteral Stones;Ureteral Calculi;Nephrolithiasis
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Die Studie untersucht eine vorsorgliche Antibiotikagabe (=Prophylaxe) gegenüber keiner Antibiotikagabe (=Placebo) der Stosswellentherapie von Harnsteinen.
Interventions
(Data source: WHO)
Drug: Ciprofloxacin;Drug: Placebo
Criteria for participation in trial
(Data source: BASEC)
- Patienten >/= 18 Jahre
- Harnsteine (das heisst Nierensteine oder Harnleitersteine)
- geplante Extrakorporale Stosswellentherapie
Exclusion criteria
(Data source: BASEC)
- ein Harnwegsinfekt vor der Operation
- eine Antibiose vor der Operation
- ein einliegender Blasenkatheter oder Nierenkatheter
- wenn während der Operation eine Harnleiterschiene eingelegt wird oder eine Blasenspiegelung stattfindet
- Allergie auf das Studienmedikament
- vorherige Teilnahme an der Studie
- Schwangerschaft
Inclusion/Exclusion Criteria
(Data source: WHO)
Inclusion Criteria:
Patients older than 18 years presenting for SWL who do not meet one of the pre-defined
exclusion criteria.
Exclusion Criteria:
- Pre-SWL urine analysis positive for nitrites
- Pre-SWL urine culture reveals >10e5 Colony Forming Unit/ml of bacteria (positive urine
culture)
- Taking antibiotics for Urinary Tract Infection (UTI) or other cause
- Suspected struvite stone (based on previous stone analysis, or partial staghorn)
- Presence of nephrostomy tube
- Requiring cystoscopy and ureteral stent insertion on the day of SWL
- Presence of Foley catheter or patient on regular clean intermittent catheterization
(CIC)
- Presence of urinary diversion (ie: ileal conduit)
- History of urosepsis prior to SWL
- Known allergic reaction to trial antibiotic
- Previous randomization in this trial
- In the opinion of the independent treating urologist, it is not in the patient's best
interest to participate
-
Further information on trial
Date trial registered
Aug 21, 2018
Incorporation of the first participant
Sep 27, 2018
Recruitment status
Recruiting
Academic title
(Data source: WHO)
A Multicenter Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
Phase 4
Primary end point
(Data source: WHO)
Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis
Secundary end point
(Data source: WHO)
Bacteriuria defined as = 100000 Colony Forming Unit/ml;Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency;Pyelonephritis or urosepsis defined as Hospital admission with fever =38.5 Celsius;Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome);Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome);Pain scale determined on a range of 0-5 with higher score indicating worse outcome
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel
Countries
(Data source: WHO)
Brazil, Canada, Finland, Indonesia, Iran, Ireland, Islamic Republic of, Russian Federation, Saudi Arabia, Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. med. Kathrin Bausch
+41 61 265 72 80
kathrin.bausch@usb.ch
Contact for general information
(Data source: WHO)
Kari AO Tikkinen, MD PhD;Philippe D Violette, MD CM
University of Helsinki;McMaster University
+358-40-6510530
kari.tikkinen@helsinki.fi
Contact for scientific information
(Data source: WHO)
Kari AO Tikkinen, MD PhD;Philippe D Violette, MD CM
University of Helsinki;McMaster University
+358-40-6510530
kari.tikkinen@helsinki.fi
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date of authorisation by the ethics committee
11.09.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01425
Secondary ID (Data source: WHO)
CLUE
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