Assessments | Pre-screening activity | Screening2and Randomization | While on treatment3 | Follow-up period | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Day of study | Pre-3rdor 4thdose of vancomycin | 1-61 | 7 (+/-3) | 8-131 | 14 (+/-3) | 15-201 | 21 (+/-3) | 22-271 | 28 (+/-3) | 29-341 | 35 (+/-3) | 36-411 | 42 (+/-3) | 43-481 | 49 (+/-3) | 50-551 | 56 (+/-3) | 60 days after index culture15(-7 or + 14 days) | ||
Informed consent | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Review of eligibility criteria | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization and dosing 4 | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographics | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical history 5 | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Physical examination 6 | Â | x | Â | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | x |
Adverse event monitoring 7 | Â | Â | Â | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Concomitant medication monitoring 8 | Â | x | Â | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
Adherence check | Â | Â | Â | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | Â |
Vancomycin MIC 9 testing | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
FBC 10 | Â | x | Â | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â |
Creatinine 11 | Â | x | Â | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â |
CK 12 | Â | x | Â | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â |
Vancomycin trough level 13 | Â | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â | x | Â |
Daptomycin trough and peak level 14 | Â | Â | Â | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Blood culture | x15 | Â | To be done daily until two consecutive negative sets | x | ||||||||||||||||
CXR 16 | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Echocardiogram 17 | Â | Â | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Urine pregnancy test 18 | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Charlson comorbidity index | Â | x | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |