The following definitions will be used.
Clinical cure is defined as being alive with the absence of fever (temperature < 38.0°C) and the resolution of UTI symptoms (either absence of symptoms or at least 2 points improvement on a 0 through 5 points severity score) through the post-treatment visit whereas no additional antimicrobial therapy for a relapse of UTI is described.
Clinical treatment failure is the opposite of clinical cure and defined as deterioration, persistent fever and/or symptoms of UTI (less than 2 points improvement on a 0 through 5 points severity score) or relapse of UTI with the same uropathogen for which additional antimicrobial treatment is prescribed.
Clinical recurrence is defined as any clinical UTI after clinical recovery and the end of treatment period including uncomplicated UTI, complicated UTI and acute pyelonephritis as defined previously [
19]. Based on microbiological typing of isolated uropathogen distinction will be made between clinical relapse, being the same uropathogen or clinical reinfection with a different uropathogen.
Pre-treatment significant growth of uropathogens is defined as ≥ 10
4 colony forming units/mL in women (midstream urine) or ≥ 10
3 colony-forming units/mL in men (midstream urine) or ≥ 10
3 colony-forming units/mL (catheter urine) or ≥ 10
2 colony-forming units/mL of midstream urine collected during antibiotic treatment of UTI at study entry [
19].
Bacteriologic cure or eradication is defined as the elimination of the study entry uropathogen or as pathogen growth of less than 10
4 colony forming units/mL in women or less than 10
3 colony-forming units/mL in men, of a midstream urine sample collected combined with the disappearance of leucocyturia [
19].
Bacteriologic failure through the 10- to 18-day post-treatment visit is defined as the absence of bacteriologic cure and classified as persistence of the original pathogen or superinfection with a new pathogen on the basis of species determination and antibiogram or an alternative method, such as Amplified Fragment Length Polymorphism or sequence-based PCR using repetitive extragenic palindromic primers.
Ciprofloxacin resistance of uropathogens is defined by a MIC > 4 mg/L and includes all
Enterococcus spp. Acute complicated pyelonephritis is defined as febrile urinary tract infection in a person with one or more of the following baseline characteristics: male sex, postmenopausal (female aged ≥ 50 years), underlying urinary tract disorder (e.g. nephrolithiasis, urologic malignancy, vesicoureteral reflux, urethral stricture), diabetes mellitus, immunocompromised, renal insufficiency or progressive UTI despite antimicrobial UTI treatment.
Co-morbidity is defined as the presence of any urinary tract disorder, heart failure, cerebrovascular disease, renal insufficiency, diabetes mellitus, malignancy or chronic obstructive pulmonary disease for which the patient is prescribed medication and/or consults a hospital-based medical specialist.