Study visit/observation point | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Screening | Randomisation | Follow-up | |||||
Timeline (study day) | 0–5 | 5 | 8 | 12 | 30 | 60 | 90 |
Window period (days) | ±1 | ±1 | ±2 | ±2 | ±7 | ±14 | ±21 |
Informed consent | X | (X) | (X) | (X) | |||
Entry criteria | X | ||||||
CRP measurement* (2 mL blood) | X | X | |||||
AEs reviewed | X | X | |||||
SAEs reviewed | X | X | X | X | X | ||
Other outcomes data collected | X | X | X |
*The CRP will not be requested in patients whose antibiotic therapy has already been discontinued.
AE, adverse events; CRP, C reactive protein; SAE, serious adverse events.