Early oral step-down antibiotic therapy versus continuing intravenous therapy for uncomplicated Gram-negative bacteraemia (the INVEST trial)

简要总结

主要结局

次要结局

• Compare between standard and intervention arms: All-cause mortality at days 14 and 90 from the time of randomisation
• Duration of survival from the time of randomisation until day 90
• Number of days on IV antibiotic therapy in the total index hospitalisation (including outpatient parenteral antibiotic therapy [OPAT]) for surviving participants from the time of randomisation until i. hospital discharge and ii. day 90
• Number of days alive and free of antibiotics (i. for all antibiotics and ii. for IV antibiotics) between the time of randomisation and day 90
• Adverse events from the time of randomisation until day 90 including: C. difficile-associated diarrhoea Peripherally inserted central catheter and other central venous catheter complications requiring line removal during index hospitalisation from the time of randomisation Liver function test abnormalities or kidney injury
• Change in treatment strategy (e.g. switch to IV antibiotics from allocated oral antibiotics or vice versa) between the time of randomisation and day 30 due to: An adverse event deemed by the treating doctor to be of sufficient severity to change treatment strategy Presumed lack of efficacy of treatment strategy according to the judgement of treating doctor
• Time to being discharged alive from the total index hospitalisation (including OPAT and hospital in the home) between the time of randomisation and day 90 (note: any death occurrence within 90 days will be considered ‘90 days’)
• Number of days alive and not in hospital (including OPAT) between the time of randomisation and day 90
• Readmission or extended hospitalisation by day 90. Readmission is defined as a new hospitalisation for any cause or a return to ambulatory hospital services occurring after discharge from the index hospitalisation. Extended hospitalisation is defined as >14 days of hospital LOS starting from the day of randomisation.
• Health economic evaluation, including estimation of total healthcare cost (from healthcare system and patient perspective)* and assessment of patient’s quality of life via EQ-5D by day 90 *Cost savings/effectiveness analyses will be performed in selected hospital sites