TABLE 1.

Definitions of clinical and by-patient bacteriologic outcomes

Clinical outcome and result	Definition of response
Clinical outcome
Cure	Resolution of all signs and symptoms of UTI
Improvement	Resolution or reduction of the majority of the original signs and symptoms of UTI, with no new or worsened symptoms
Failure	No resolution and no reduction of a majority of original signs and symptoms, worsening of one or more of the above, new signs or symptoms, or the need for intervention with other antimicrobial agents
Indeterminate	Lack of necessary information (e.g., the patient was lost to follow-up)
Recurrence	Development of new or worsened signs or symptoms of UTI at the LFU visit in those patients who had a clinical response of cure or improvement at their TOC visit
Bacteriologic outcome
Eradication	All baseline pathogens present at ≤104 CFU/ml at the TOC visit
Persistence	Presence of any baseline pathogen at >104 CFU/ml at TOC
Presumed persistence	No culture results at TOC but a clinical response of failure at TOC
Superinfection	Emergence of a new (nonbaseline) pathogen at ≥105 CFU/ml at or before TOC, together with signs or symptoms of UTI
Colonization (low-level bacteriuria)	Emergence of a new (nonbaseline) pathogen after the start of treatment, but at <105 CFU/ml or not accompanied by signs or symptoms of UTI
Relapse	Eradication of baseline pathogen(s) at TOC, with subsequent appearance of the same pathogen at >103 CFU/ml
Reinfection	Eradication of baseline pathogen(s) at TOC, with subsequent appearance of a new pathogen at ≥105 CFU/ml accompanied by signs or symptoms of UTI
Indeterminate	No information available
Overall Outcome
Success	Clinical response of cure or improvement plus bacteriologic response of eradication without changing or adding to the antibiotic regimen
Failure	All other outcomes