Table 3 Summary of analyses of the primary outcomes

IV antibiotic duration

Primary analysis:

Cox regression (superiority)

Trial arm and minimisation factors

Kaplan Meier plot

Trial arm

Log rank test

Trial arm

Sub-group analyses:

Cox regression (interaction test by model comparison)

Trial arm, minimisation factors, and organ system of infection (lower urinary, lower respiratory, intra-abdominal, bacteraemia, skin, soft tissue)

Trial arm, minimisation factors, and whether patients were recruited before or after the pause in recruitment due to COVID-19

Complier Average Causal Effect (CACE)

Trial arm, minimisation factors, and intervention adherence (“Analysis populations” section)

Survivor Average Causal Effect (SACE)

Trial arm, minimisation factors, and mortality before stopping IV antibiotic use (“Sensitivity analyses” section)

Safety composite

Primary analysis:

Logistic regression (non-inferiority)

Trial arm and minimisation factors

Sub-group analyses:

Logistic regression (interaction test by model comparison)

Trial arm, minimisation factors, and organ system of infection (lower urinary, lower respiratory, intra-abdominal, bacteraemia, skin, soft tissue)

Trial arm, minimisation factors, and whether patients were recruited before or after the pause in recruitment due to COVID-19

Complier Average Causal Effect (CACE)

Trial arm, minimisation factors, and intervention adherence (“Analysis populations” section)