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Table 2 Endpoints, provided with definitions and a time frame

From: Oral fosfomycin versus ciprofloxacin in women with E.coli febrile urinary tract infection, a double-blind placebo-controlled randomized controlled non-inferiority trial (FORECAST)

Endpoint Definition 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
  1. aOther strains in urine culture will be reported, but do not fall within this definition