All patients
|
Eligibility assessment
|
X
| | | | | | | | | | | |
Patient information sheet and consent
|
X
| | | | | | | | | | | |
Randomisation
| |
X
| | | | | | | | | | |
Clinical assessment(a)
| |
X
| | |
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
Resource utilisation(b)
| |
X
| | | | |
X
| |
X
|
X
|
X
| |
EQ-5D
| |
X
| | | | |
X
| |
X
| |
X
|
X
|
Blood culture with sensitivities (10 ml)(c)
|
(X)
|
X
| | |
X
| |
X
| | | | |
X
|
EDTA blood(d) (1.5 ml)
| |
X
| | | | | | | | | | |
Clotted blood(e) (5 ml)
| | | | | | | | | | | | |
CRP
|
(X)
|
X
| | |
X
| | |
X
|
X
| | |
X
|
ALT, ALP, bilirubin
|
(X)
| | | |
X
| | |
X
| | | | |
Serum storage
| |
X
| | |
X
| | | |
X
| | | |
Whole blood(f) (5 ml)
| |
X
| | | | | | | | | | |
Subset of patients recruited to the intensive PK/PD substudy
(g)
|
Lithium heparin blood (3 × 3 ml/ time point) for antibiotic concentration assays(h)
| |
X
| | |
X
| |
X
| | | | | |
Lithium heparin blood (10 ml) for compartment studies(i)
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| | | |
Clotted blood(e) (5 ml)
| | | | | | | | | | | | |
CRP
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| | |
X
|
ALT, ALP, bilirubin
| | | | |
X
| | |
X
| | | | |
Creatinine
| |
X
| | |
X
| | |
X
| | | | |
Serum storage
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| | |
X
|
Blood culture (10 ml)
| |
X
|
X
|
X
|
X
|
X
|
X
|
X
|
X
| | |
X
|
Subset of patients recruited to the sparse PK/PD substudy
(j)
|
Lithium heparin blood (3 × 3 ml in total) for antibiotic concentration assays(j)
| |
X
| | |
X
| | | | | | | |
Clotted blood(e) (5 ml)
| | | | | | | | | | | | |
CRP
| |
X
| | |
X
| | |
X
|
X
| | |
X
|
ALT, ALP, bilirubin
| | | |
X
| | |
X
| | | | | |
Creatinine
| |
X
| | | | | | | | | | |
Serum storage
| |
X
| | |
X
| | | |
X
| | |
X
|
Blood culture (10 ml)
| |
X
|
X
|
X
|
X
| |
X
| | | | |
X
|