Study period | |||||||
---|---|---|---|---|---|---|---|
Day 0 | Study visits and procedures | ||||||
Pre-consent (standard care) | Pre-randomisation | Randomisation | Day 1–2 | Day 3–5 | Day 6–14 | Day 28 | |
Pre-consent eligibility screening | |||||||
Eligibility screening as appropriate (as per standard care), e.g., ANC, AST/ALT, creatinine, blood culture. When available, Hb, platelets, CRP, albumin, lactate | X | ||||||
Informed consent | |||||||
Informed consent obtained | x | ||||||
Pre-randomisation eligibility and assessments | |||||||
Eligibility screening as appropriate (non-standard care) e.g., pregnancy test, MASCC score, max temp prior to randomisation, signs/symptoms of sepsis | x | ||||||
EQ-5D-5 L | x | ||||||
Randomisation | |||||||
Standard care antibiotic administration | X | x | x | x | x | ||
Intervention (early switch) antibiotic administration (IV antibiotics will commence prior to informed consent) | X | x | x | x | x | ||
Research blood sample | x | ||||||
GP letter sent | x | ||||||
Baseline assessments to be completed on CRF after eligibility is confirmed | |||||||
Demographics, vital signs, cancer, medical and SACT history, hospital admission details | x | ||||||
Concomitant medications | x | x | x | x | x | ||
Relevant microbiological results | x | x | x | x | x | ||
Daily data collection | |||||||
Antibiotic regimen | X | x | x | x | x | x | |
Highest daily temperature (whilst inpatient or temperature recorded if unwell as an outpatient) | X | x | x | x | x | x | |
Protocol compliance | |||||||
Adherence to protocol specified intervention | x | x | |||||
Patient follow-up | |||||||
Survival status | x | x | |||||
EQ-5D-5 L | x | ||||||
Patient follow-up questionnaire | x | ||||||
New medications | x | x | |||||
Changes to next planned SACT cycle | x | ||||||
Hospital discharge/re-admission/critical care admission details | x | x | |||||
Recording and reporting of adverse events | x |