|
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