Screening | Treatment | EOS | ||
---|---|---|---|---|
Visit number | 0 | 1 | 2 | 3 |
Day | -5 to -1 | 1 | 7 to 11(EOT) | 85 to 99 |
Informed consent | X | |||
Check in/exclusion criteria | X | |||
Randomization | X | |||
Demographic data | X | |||
Medical history | X | |||
Charlson score | X | |||
Pitt bacteremia score | X | |||
Current medication | X | X | X | X |
Infective focus | X | |||
Clinical data | ||||
Physical examination | X | X | ||
Vital signs | X | X | ||
Outcome assessment | ||||
SAB-related complications | X | X | ||
Length of stay (in days) | X | X | ||
90-day mortality | X | |||
Safety | ||||
Adverse events | X | X | X | |
Clostridium difficile-associated diarrhea | X | X | X | |
Complications of iv therapy | X | X | X | |
Laboratory data | ||||
The following routine laboratory results are documented once from day −3 to 1, if available: Hemoglobin, red and white blood cell count, platelet count, serum sodium, serum potassium, serum creatinine, liver function tests, creatine phosphokinase, C-reactive protein, blood culture | X | |||
Pregnancy test in premenopausal women | X |