Table 3.

Study time and event schedule

^aWritten informed consent at screening or day 1 prior to any study procedure. Continue to obtain verbal consent for the continuation of participation

^b Females of child-bearing potential. Only required if routine clinical pregnancy test result is not available. Urine or blood test as per local practice. Where possible in unison with other routine clinical tests

^cIf participant remains/remained on study treatment

^dClinician decision to cease or continue study medication up to and including day 14

^eOnly if the participant remains in the hospital

^f If participant remains on study treatment or within 24 h of the last dose of study treatment

NB. Index blood culture and any subsequent blood cultures will be taken as part of routine clinical practice during the 30-day trial period if the participant is febrile—defined as temperature ≥ 38.0 °C

Routine clinical haematology and biochemistry results will be used to calculate SOFA, mSOFA and CrCl