Table 2.
Primary and secondary outcomes (Intention to Treat and Per Protocol populations)a
| Outcomes | Intention to treat population | Per protocol population | ||||||
|---|---|---|---|---|---|---|---|---|
| 7-day group N = 59 |
14-day group N = 47 |
Risk difference (95% CI) |
P value | 7-day group N = 47 |
14-day group N = 28 |
Risk Difference (95% CI) |
P value | |
| Primary outcome | ||||||||
| Clinical failure | 25 (42.4) | 21 (44.7) | − 2.3 (− 21.3 to 16.7) | 0.98 | 22 (46.8) | 14 (50) | 3.2 (− 26.57 to 20.19) | 0.98 |
| 28-day mortality | 22 (37.3) | 19 (40.4) | − 3.1 (− 21.8 to 15.5) | 0.90 | 19 (40.4) | 12 (42.9) | − 2.4 (− 25.51 to 20.65) | 0.99 |
| Relapse | 5 (8.5) | 2 (4.3) | 4.2 (− 4.93 to 13.37) | 0.64 | 5 (10.6) | 2 (7.1) | 3.5 (− 9.49 to 16.49) | 0.93 |
| Secondary outcomes | ||||||||
| Days alive and free from hospitalisationb | 0 (0–4) | 0 (0–3) | – | 0.79 | 0.0 (0.0–1.0) | 0.0 (0.0–4.0) | – | 0.80 |
| Days alive and free from any antibiotic therapyb | 11.5 (0–25) | 3 (0–17) | – | 0.08 | 12.0 (0.0–25.3) | 0.0 (0.0–20.0) | – | 0.09 |
| New infections caused by other bacteria (independent of susceptibility profile) | 18 (30.5) | 17 (36.2) | − 5.7 (− 23.74 to 12.42) | 0.68 | 17 (36.2) | 7 (25) | 11.2 (− 9.95 to 32.29) | 0.46 |
| New infections caused by other MDR-GNB | 11 (18.6) | 9 (19.2) | − 0.5 (− 15.51 to 14.51) | 0.99 | 11 (23.4) | 1 (3.6) | 19.8 (5.91 to 33.75) | 0.05 |
| Length of ICU stayc | 8.0 (2.8–22.0) | 7 (3.0–20.3) | – | 0.81 | 8.0 (4.0–21.0) | 4.0 (3.0–22.0) | – | 0.76 |
| Adverse events | ||||||||
| Acute Kidney Injury | 30 (58.8) | 22 (52.4) | 6.4 (− 13.82 to 26.7) | 0.68 | 25 (58.2) | 13 (48.2) | 10.0 (− 13.94 to 33.92) | 0.5684 |
| KDIGO 1d,e | 9 (17.65) | 6 (14.29) | 8 (18.6) | 3 (11.1) | ||||
| KDIGO 2d,e | 10 (19.6) | 2 (4.8) | 7 (16.3) | 2 (7.4) | ||||
| KDIGO 3d,e | 11 (21.6) | 14 (33.3) | 10 (23.3) | 8 (29.6) | ||||
| Diarrhoea | 27 (45.8) | 20 (42.6) | 3.2 (− 15.8 to 22.22) | 0.89 | 21 (44.7) | 13 (46.4) | − 1.8 (− 25.06 to 21.56) | 0.99 |
|
Clostridioides difficile confirmed infection |
3 (5.1) | 1 (2.1) | 3.0 (− 4 to 9.92) | 0.78 | 3 (6.4) | 0 (0) | 6.4 (− 0.61; 13.37) | 0.45 |
| Othersf | 1 (0.94) | 0 (0) | 1.7 (− 1.6 to 4.98) | 0.99 | 1 (2.1) | 0 (0) | 2.1 (− 2 to 6.26) | 0.99 |
| New hemodynamic instability | 16 (27.1) | 8 (17.0) | 10.1 (− 5.52 to 25.72) | 0.32 | 13 (27.7) | 3 (10.7) | 17.0 (− 0.22 to 34.12) | 0.15 |
Data presented as n (%) or median (IQR p25-p75). MDR-GNB Multidrug-resistant Gram-negative bacteria, ICU intensive care unit
aPrimary and secondary outcomes were assessed within 28 days of randomisation, with exception of new hemodynamic instability which were assessed in 14 days. All but one patient was followed-up until the 28th day
bTotal (N = 103), 7-day group (n = 58), 14-day group (n = 45)
cTotal (N = 62), 7-day group (n = 36, 14-day group (n = 26)
dIntention to treat population: Total (N = 93), 7-day group (n = 51), 14-day group (n = 42)
ePer protocol population: Total (N = 70), 7-day group (n = 43), 14-day group (n = 27)
fSeizure (n = 1)