Table 3.

Endpoints in ASTARTÉ

Endpoint	Description	Time of evaluation
Primary endpoint
Clinical success	Proportion of patients with all of the following: (1) clinical cure at TOC (see below); (2) alive at day 28; (3) no need to stop the study drug because of adverse event, failure or intercurrent infection; (4) no need to prolong treatment after 14 days and (5) no recurrence of the infection at day 28	Test of cure (7–10 days after end of treatment)
Secondary endpoints
Clinical cure	Proportion of patients showing resolution of the new signs/symptoms related to the infection	Test of cure (7–10 days after end of treatment)
Mortality	Proportion of dead patients	Day 28
Length of hospital stay	Average time from randomisation to hospital discharge	Hospital discharge
Adverse events	Proportion of patients with any adverse event from first dose of study drug; also of severe adverse events (standard definition)	Day 28
Development of resistence	Proportion of patients with new isolation of the causative micro-organism in follow-up cultures showing resistant to temocillin or meropenem	Day 28
Recurrence	Proportion of patients with development of signs/symptoms of the infection caused by the same micro-organism after clinical response has been reached	Day 28
Reinfection	Proportion of patients with occurrence of a new infection caused by a different micro-organism	Day 28
Change in SOFA score (descriptive endpoint)	Average change in SOFA score	All follow-up visits
Temocillin serum concentrations (descriptive endpoint; only one site)	Distribution of temocillin serum concentration	See text
Temocillin MIC according to mechanisms of resistance (descriptive endpoint)	Distribution of temocillin MIC according to the mechanisms of resistance to cephalosporins	See text

MIC, minimum inhibitory concentrations; SOFA, Sequential Organ Failure Assessment; TOC, test of cure.