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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.