Table 2

Schedule of enrolment, interventions and assessments

Data type		Source data	Data type	Screening	Baseline	Postrandomisation until discharged home	Follow-up (day 28)	Frequency	By whom
1	Informed consent	Consent form	–	X				Once	Site clinical/research team
2	Eligibility assessment	Eligibility Case Report Form (CRF)	–	X				Once	Site research team
3	Demographics	CRF			X			Once	Research nurse
4	Admission data	CRF	Comorbidities, preadmission antibiotic use, initial working diagnosis		X			Once	Research nurse
5	Health-related quality of life	Questionnaire	CHU9D		X		X	Twice	Patient/parent reported (over telephone or post at day 28)
6	Randomisation	CRF	–		X			Once	Site research team
7	Antibiotic use (intravenous/oral)	Observation charts/medical notes	Antibiotic type, dose, duration			X		Daily	Research nurse
8	Blood tests including PCT	CRF/medical notes	Routine blood tests PCT results (for those in intervention arm)			X		As required	Research Nurse
9	Clinical review	CRF/medical notes	Clinical decision made and whether the algorithm was complied with			X		As required when a clinical decision has been made	Site Clinical/ Research team
10	Cerebrospinal fluid metrics, radiology and microbiology	CRF/medical notes	White cell count, biochemistry. Microbiology results, radiology results			X		As required	Research nurse
11	Re-commencing of Antibiotics (intravenous and oral	Observation charts/medical notes	Antibiotic type, dose, duration, time recommenced			X		Daily	Research nurse
12	Unscheduled admissions	Medical notes	PICU readmissions post discharge			X		Daily	Research nurse
13	Mortality	Medical notes	Date, description			X		If before day 28	Research nurse
14	Discharge	Medical notes	Date, description			X		If before day 28	Research nurse
15	Adverse events	Observation charts/medical notes	Date, type			X		Daily	Research nurse
16	Suspected adverse drug reactions (ADR)	Liverpool Causality Assessment tool	Date, description			X		Daily	Research nurse
17	Resource use	Questionnaire	Direct medical costs (Inc. medication and ventilation and vasopressor) and resource use				X	Once	Patient/parent reported (over telephone or post)
18	SAE	SAE form			←-------------------------As required-----------------------→				Research nurse
19	Withdrawals	Withdrawal form			←-------------------------As required-----------------------→				Research nurse, centre for trial research

CHU9D, Child Health Utility questionnaire; PCT, procalcitonin; PICU, paediatric intensive care unit; SAE, serious adverse event.