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Table 1 Inclusion and exclusion criteria of the UROPOT trial

From: UROPOT: study protocol for a randomized, double-blind phase I/II trial for metabolism-based potentiation of antimicrobial prophylaxis in the urological tract

Participants fulfilling all the following inclusion criteria are eligible for the study:

1. Written informed consent

2. Adults (≥18 years)

3. Patients with a ureteral stent in situ

4. Patients scheduled for endourological ureteral manipulations (e.g. endourological stone surgery, ureteral stent exchange)

5. Asymptomatic bacteriuria with strains of E. coli and/or K. pneumoniae sensitive to ceftriaxone and amikacin.

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

1. Allergy to one of the study drugs or excipients (Beta-lactams, aminoglycosides or mannitol)

2. Pregnant and lactating women

3. Glomerular filtration rate (CKD-EPI eGFR) < 50ml/min / 1,73m2

4. Middle to severe hearing impairment

5. Myasthenia gravis or other forms of myoneural disorders

6. Congestive heart failure, pulmonary oedema

7. Intracranial haemorrhage, compromised blood-brain barrier

8. Antibiotic treatment within 14 days prior to randomization

9. Mixed cultures of E. coli and/or K. pneumonia with other bacteria

10. Previous (within 3 months prior to randomization) or concomitant participation in another interventional clinical trial

11. Inability to understand and follow the protocol

12. Inability to give informed consent