A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards

Table 3 Clinical outcomes in the BALANCE-Ward pilot RCT compared to the BALANCE-ICU pilot RCT and updated data from the BALANCE main RCT

Outcome	BALANCE Ward Pilot n = 134	BALANCE ICU pilot n = 115	BALANCE Main RCT^a n = 600	P value Ward pilot vs ICU pilot	P value Ward pilot vs main RCT
Mortality
In hospital	3/134 (2)	15/115 (13)	95/597 (16)	0.001	< 0.001
At 90 days^b	17/133 (13)	17/115 (15)	104/600 (17)	0.65	0.20
Length of stay in hospital (in days)	6 (4–12)	20 (12–43)	20 (11–43)	< 0.001	< 0.001
Relapse of bacteremia	1 (1)	4 (3)	12 (2)	0.18	0.48
Antibiotic-free days (by day 28)	14 (14–21)	14 (8–17)	14 (6–18)	< 0.001	< 0.001
Antimicrobial-related adverse outcomes
Allergy	0 (0)	0 (0)	9/598 (2)	1.00	0.38
Anaphylaxis	0 (0)	0 (0)	0/598 (0)	1.00	1.00
Acute kidney injury	0 (0)	0 (0)	1/598 (0.2)	1.00	1.00
Acute hepatitis	0 (0)	1 (1)	2/598 (0.3)	0.46	1.00
Clostridiodes difficile infection	0 (0)	4 (3)	12/598 (2)	0.04	0.14
Secondary infection with resistant microorganisms	11 (8)	10 (9)	72 (12)	0.89	0.18

All data are presented as medians and interquartile ranges unless otherwise specified
^a Based on up-to-date data from the first 600 ICU patients enrolled in the BALANCE main RCT
^b One patient loss to follow-up for 90-day outcome (but ongoing efforts underway to ascertain vital status)

ISSN: 1745-6215