Table 3.

Data collection

	Variables
Demographic data	Age, gender, ethnicity, long-term residential care status, ward location
Trial characteristics	Date of screening and enrolment, inclusion criteria and consent details, date and time of randomization
Co-morbidities and risk factors	Charlson score, co-morbid conditions, date and type of any surgery within 14 days, use of cytotoxic chemotherapy, immune suppressive medication, radiotherapy, biological agents (for example, monoclonal antibody therapy), presence of intravascular devices or urinary catheters; use of ‘not for resuscitation’ order
Infection parameters	Bacteraemia acquisition status (community, healthcare-associated or hospital-acquired infection), presumed source of infection, ICU admission, Pitt bacteraemia score, Acute Physiology and Chronic Health Evaluation (APACHE) II score (if in ICU)
Antibiotic data	From 48 hours prior to blood culture collection and up to 30 days; dose/route/frequency recorded
Clinical observations	Daily vital signs, (highest temperature, HR, RR; lowest systolic BP), lowest arterial pCO2 (if ventilated), white cell count, use of pressors; recorded days 1 to 7; patient weight
Microbiological data	Date and time of initial blood culture, full susceptibility profile, daily blood culture results days 1 to 3; any further positive blood cultures and species identification/resistance profile; other clinical sites growing E coli or Klebsiella, any multidrug-resistant organism or C. difficile identified up to 30 days
Outcome data	Survival at 7 and 30 days post randomisation
	Date of death or discharge
	Length of hospital stay
	Days to clinical and microbiological resolution
	Clinical and microbiological success at day 4
	Microbiological resolution or relapse
	Protocol violations and adverse events
	Reasons for study withdrawal

Abbreviations: BP blood pressure, HR heart rate, RR respiratory rate.