Table 2 Study visits

Visits

Pre-screening

Screening/information visit 0

Phone contact

Visit 1

Visit 2

Visit 3

Assessment of potentially eligible patients

x

Assessment of eligibility during standard clinical consultation:

Inclusion/exclusion criteria check

x

x

Participant information and delivery of informed consent

x

Information about urinary culture results and feasibility to participate in the trial

x

Informed consent and randomization:

Signature informed consent

x

Randomization allocation

x

Interventions:

Dispensation of study medication

x

Transurethral intervention (ureteral stent manipulation)

x (+ 4–6 h)

Assessments:

Patient history, physical exam, pregnancy test

x

Ureteral stent discomfort questionnaire

x

x

x

Vital signs (temperature, blood pressure, heart rate, and respiratory rate)

x

x

x

x

Blood draw for analyses: sodium, potassium, creatinine, eGFR (CKD-EPI), complete blood count

x^a

x^b

x

x^c

Urine sampling for analyses: urine culture (microbiology)

x^a

x^b

x

x

Assessment of anti-biofilm activity (secondary outcome)

x

Blood draw for analyses: aminoglycoside + mannitol level (AMK/Man level) at 1, 3, and 6 h after administration of drug

x

Urine sampling for analyses: ceftriaxone, mannitol, and aminoglycoside levels in urine

x (during intervention)

x

Assessment of post-interventional clinical UTIs (primary outcome)

x

X