Table 1

Outcome definitions and time frames

Primary endpoint and time frameDefinition and assessment
Clinical cure
Days 3–5 after treatment*
TOC, the situation where all the following conditions are met: survival at the time of the evaluation; complete resolution of all symptoms and signs of infection (or return to the situation prior to current infection); no need for prolonged antibiotic treatment beyond the recommended duration* and no need for treatment modification due to unfavourable clinical response.