Day | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Screening | 0 | 1 | 2 | 3 | 5 | 7 | 10 | 14 | Weekly until discharged | 84 | Potential failure/recurrence | |
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 |