Outcome | BALANCE Ward Pilot n = 134 | BALANCE ICU pilot n = 115 | BALANCE Main RCTa 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 daysb | 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 |