Table 3.
Study period | ||||||||
---|---|---|---|---|---|---|---|---|
Enrolment | Allocationa | Monitoring during treatment | End of treatment | Follow-up since randomization (months) | ||||
Study phase | Admission to randomization | Weekly | Bi-weekly | 3 | 6 | 12b | ||
Enrolment | ||||||||
Eligibility screen | ✓ | |||||||
Informed consent | ✓ | |||||||
Cranial imaging | − 3 to 0 days | |||||||
Allocation | ✓ | |||||||
Intervention | ●-------------------------------------------------------------● | |||||||
Assessments | ||||||||
E-GOS | ✓ | ✓ | ✓ | ✓ | ||||
Clinical examination | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Cranial imaging | ✓ | ✓ | ✓ | ✓ | ||||
Morisky scores (oral arm) | ✓ | |||||||
Blood tests | ✓ | ✓ | ✓ | ✓ | ✓ | |||
SF-36 + EQ-5D-5L + MoCA | ✓ | ✓ | ✓ | ✓ | ✓ | |||
Screening for immunodeficiency | ✓ | ✓ |
E-GOS Extended Glasgow Outcome Scale score. Blood tests include c-reactive protein, complete blood count, creatinine, liver function tests
aAfter 14 days or longer since definitive neurosurgical treatment or IV antibiotic therapy for brain abscess
bCan be replaced by telephone consultation