Table 2 Endpoints, provided with definitions and a time frame

Clinical cure

Alive with reduction of all initial local and systemic FUTI related symptoms and without additional systemic antibiotic therapy for UTI (except antibiotic prophylaxis)

6–10 days post-end of-treatment (PET) + 30–35 days PET

Microbiological cure

Negative urine culture for E.coli (< 10³ CFU/ml), phenotypically identifiable to the initial culture (assessment by microbiologist) ^a

6–10 days PET

Acquired resistance

Resistance to ciprofloxacin, fosfomycin or new ESBL-producing bacteria in phenotypically identical strain

6–10 days PET

Mortality

-Mortality for any reason

Within 30–35 days PET

-Mortality related to UTI or study medicines

ICU admission

-ICU admission for any reason

Within 30–35 days PET

-ICU admission related to UTI or study medicines

Readmission

-Readmission for any reason

Within 30–35 days PET

-Readmission related to UTI or study medicines

Relapse

Development of new symptoms of UTI after previous clinical and microbiological cure with a phenotypically identical strain as isolated during the initial blood or urine (≥10³) cultures.

Within 30–35 days PET

Reinfection

Same definition as relapse, but with phenotypically different strains isolated in cultures (urine, ≥10³)

Within 30–35 days PET

Additional antibiotic use

Additional systemic antibiotic therapy for UTI (except antibiotic prophylaxis)

Within 30–35 days PET

Length of hospital stay

-Total days of hospital stay

Within 30–35 days PET

-Total days of ICU stay

Days of absenteeism

Converted to full work days:

Within 30–35 PET

-Paid work

-Voluntary work

Adverse events

Possible or probable related to study protocol

Within 30–35 days PET

Early study medicine discontinuation

Early study medicine discontinuation:

–

-because of intolerance/adverse events

-because of clinical failure

-because of resolution of symptoms