Potentiated Aminoglycosides in Postoperative Urinary Tract Infection Prophylaxis (UROPOT)
Urinary Tract Infections, Urological System Complication of Procedure
About this trial
This is an interventional prevention trial for Urinary Tract Infections
Eligibility Criteria
Inclusion Criteria: Written informed consent Adults (≥18 years) Ureteral stent in situ Patients scheduled for endourological ureteral manipulations (e.g. endourological stone surgery, ureteral stent exchange) Asymptomatic bacteriuria with strains of E. coli and/or K. pneumoniae sensitive to Ceftriaxone and Amikacin/Aminoglycosides. Exclusion Criteria: Allergy to one of the study drugs Beta-lactams, aminoglycosides or mannitol Pregnant and lactating women Glomerular filtration rate (CKD-EPI eGFR) < 50ml/min / 1,73m2 Hearing impairment Myasthenia gravis or other forms of myoneural disorders Congestive heart failure, Pulmonary edema Intracranial hemorrhage, blood-brain barrier compromise Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial Antibiotic treatment within 14 days prior to randomization Mixed cultures of E. coli and/or K. pneumonia with other bacteria Inability to understand and follow the protocol Inability to give informed consent BMI<20 or >30
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
Ceftriaxone (CRO)
Aminoglycoside (AMK)
AminoglycosideLD + Mannitol (AMK1/2 + MAN)
Ceftriaxone infusion. Ceftriaxone is a beta-lactam antibiotic that is the standard-of-care antibiotic for prophylaxis of asymptomatic bacteriuria in Switzerland. The choice of 2000 mg delivered intravenously reflects the general practice.
Amikacin infusion Amikacin is an aminoglycoside routinely used in Australia (e.g. amikacin, gentamicin) as the standard of care for antibiotic prophylaxis for endourological treatments. It is also used globally for fever in neutropenia in hematological patients. Due to their relatively limited use, aminoglycosides have low resistance rates amongst Enterobacteriaceae. A single dose of 1000mg will be used intravenously
Amikacin + Mannitol combination The addition of Mannitol enhances bactericidal effect of amikacin in E.coli and K.pneumoniae in animal models and allows for a decrease of amikacin dosing. A single dose of 500mg (low dose or LD - decrease by 50%) systemic amikacin will be used intravenously in combination with 5 grams mannitol delivered intravenously.