Table 4.
Schedule of follow-up visits and procedures
| Assessment | Day 0 | Visit 1 selection (Day 1) |
Visit 2 (Day 3) |
Visit 3 End of treatment (Days 7–14), |
Visit 4 Test of cure (14–24) |
Visit 5 Day 28 (±5) |
Unscheduled visit |
| Randomisation | X | ||||||
| Informed consent | X | ||||||
| Inclusion/exclusion criteria | X | ||||||
| Pregnancy test | X | ||||||
| Clinical history | X | X | X | X | X | X | |
| Physical examination | X | X | X | X | X | X | |
| SOFA scale | X | X | X | X | X | ||
| Haematology/chemistry | X | X | X | X | X | ||
| Coagulation | X | X | |||||
| Urinalysis | X | X | X | ||||
| Blood culture | X | X | X | X | |||
| Concomitant medication | X | X | X | X | X | ||
| Dispensing control | X | X | X | ||||
| Adverse events | X | X | X | X | X |
*Day 0 is the day of blood culture. Day 1 must not exceed 96 hours after blood culture was drawn.
†If applicable.
‡The visit can be done by telephone if patient is not hospitalised. In this case, physical examination, blood extraction and SOFA scale are not needed.
§If applicable.
¶If it has not been realised in the previous 72 hours.
**Only in urinary tract infection.
††Only if fever persists since visit 2. Repeat it in 48 hours if positive.
‡‡Between 7 and 14 days from the start of the antibiotic treatment.
§§Day 28 (±5 days) since randomisation.
¶¶7–10 days after the end of the treatment.
SOFA, Sequential Organ Failure Assessment.