Visit 1a Screening and randomisation visit | Visit 1b Treatment initiation visit | Visit 2 Renal function measurement visit | Visit 3 Early on treatment visit | Visit 4 a Day 5 ± 1/ End of Allocated Therapy (optimised arm) | Visit 5 End of allocated Therapy (standard arm) visit | EVT b | Visit 6 Test of Cure visit | Visit 7 Short-term follow-up visit | Visit 8 Audiology follow-up visit | |
---|---|---|---|---|---|---|---|---|---|---|
Timing | Day 0 | Maximum of 24 h after randomisation | Between Visit 1b and Visit 3 | 72 ± 8 h after initiation of study vancomycin | 5 ± 1 days from initiation of study vancomycin a | 10 ± 2 days from initiation of study vancomycin | End of primary course of vancomycin b | 10 ± 1 days after end of study vancomycin | 30 ± 5 days from initiation of study vancomycin | Up to Day 90 from initiation of study vancomycin |
Signed informed consent | X | |||||||||
Medical history | X | |||||||||
Adverse event reporting | X | X | X | X | X | X | X | X | X | |
Clinical examination | X | X | X | X | X | X | X | |||
Full blood count | X | (X c) | X | X | X | X | ▲ | |||
Renal function measurements | X | (X c) | X | X | X | X | X | ▲ | X | |
Glucose/Lactate/Base excess | X | (X c) | X | X | X | X | ▲ | |||
CRP | X | (X c) | X | X | X | X | ▲ | |||
Biomarker sampling | X | (X c) | X | X | X | X | X | |||
Blood culture | X d | (X c) | (X) | (X) | ||||||
Blood for bacterial DNA analysis (babies ≥ 29 weeks PMA only) | X | (X c) | X | X | ||||||
PK sampling and plasma storage e | ||||||||||
Stool/rectal swab and colonisation swab collection | X | (X c) | X f | X | X | X | ||||
Vancomycin administration | X | X | X | X | X | X | ||||
Assessment for relapse/new infection | X | X | ||||||||
Auditory screening | X |