Table 2 Secondary objectives and outcomes

1

To compare all-cause mortality of each regimen

Vital status (alive or dead)

Day 30 and day 90

2

To compare clinical and microbiologic success of each regimen at day 14

1. Vital status (alive or dead)

2. SOFA score (ICU) or modified SOFA score (non-ICU) stable or improved

3. Microbiological cure defined as no growth in blood of index isolate on day 7 or later post randomisation (taken only if the patient is febrile ≥ 38 °C, to prevent unnecessary additional protocol-driven blood collection (afebrile patients have presumed eradication)

1. Day 14

2. Day 1 and day 14

3. Day 7 to day 14

3

To compare the functional outcome of patients treated with each regimen

Baseline and 30-day post-randomisation Functional Bacteremia Outcome Score.

NB. Baseline reflects pre-admission status prior to condition meriting hospital admission.

Screening and day 30

4

To compare the rates of relapse of bloodstream infection (microbiological failure) with each regimen

Growth of the same organism as index blood culture

Post cessation of randomised treatment up to day 90

5

To compare lengths of hospital (acute) and ICU stay with each regimen

Number of days at home.

ICU ± non-ICU stay defined as duration between index blood culture and 90-day post-randomisation

Cumulative up to day 90

6

To compare the number of treatment emergent serious adverse events with each regimen

Treatment emergent serious adverse events

Day 1 to the last dose plus 5 days

7

To compare rates of Clostridium difficile infection (CDI) with each regimen

Clinician diagnosed (including a positive CDI test) and treated CDI

30 days

8

To compare rates of colonisation and/or infection with multi-resistant bacterial organisms (MROs) including those newly acquired

1. New MROs detected from any clinical specimen post cessation of randomised treatment.

MROs include vancomycin-resistant Enterococci (VRE), methicillin-resistant Staphylococcus aureus (MRSA) and multi-resistant Gram-negative organisms including carbapenem-resistant Enterobacteriaceae carbapenem-resistant Pseudomonas aeruginosa (CRP), carbapenem-resistant Acinetobacter baumannii (CRAB)

Baseline and up to day 30