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Table 3 Data collection

From: Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial

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