Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT05761405
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05761405
Study Brief:
Protocol Section:
NCT05761405