Table 2.
Clinical cure | |
---|---|
Resolution |
Disappearance of all signs and symptoms related to the infection AND No requirement for additional antibiotic treatment (except as part of de-escalation strategy) for the disease to be examined AND No initiation of antibiotic treatment for the disease to be investigated within 48 h after completion of the study drug |
Improvement |
Marked or moderate reduction in the severity and/or number of signs and symptoms of infection AND No requirement for additional antibacterial treatment (except as part of de-escalation strategy) for the disease to be examined AND No initiation of antibiotic treatment for the disease to be investigated within 48 h after completion of the study drug |
Failure | Signs and symptoms of infection persist or increase in comparison to baseline, or additional antibiotic treatment becomes necessary for the disease to be investigated |