Table 1.
Baseline characteristics of intention to treat population
| Baseline characteristics | All n = 106 |
7-day group n = 59 |
14-day group n = 47 |
|---|---|---|---|
| Age, years | 67.0 (52.3–75.3) | 67.0 (55.0–76.0) | 67.0 (49.5–75.5) |
| Female | 39 (36.8) | 22 (37.3) | 17 (36.2) |
| Race/Skin color | |||
| White/Caucasian | 68 (64.2) | 38 (64.4) | 30 (63.8) |
| Black/Brown | 36 (34.0) | 20 (33.9) | 16 (34.0) |
| Asian | 2 (1.9) | 1 (1.7) | 1 (2.1) |
| Body Mass Index (kg/m2) a | 25.5 (23.0–29.0) | 25.0 (23.0–29.0) | 26.0 (23.0–29.0) |
| Charlson comorbidity index | 1 (0–3) | 2 (0–3) | 1 (1–3) |
| Infection Site | |||
| Bloodstream infection of unknown source | 6 (5.7) | 2 (3.4) | 4 (8.5) |
|
Central Line-associated bloodstream infection |
4 (3.8) | 3 (5.1) | 1 (2.1) |
| Respiratory Tract | 73 (68.9) | 44 (74.6) | 29 (61.7) |
| Urinary | 23 (21.7) | 10 (17.0) | 13 (27.7) |
| Infection risk | |||
| Low risk | 27 (25.5) | 14 (23.7) | 13 (27.7) |
| High risk | 79 (74.5) | 45 (76.3) | 34 (72.3) |
| Severity criteria | |||
| Bloodstream infection | 8 (7.6) | 4 (6.8) | 4 (8.5) |
| Pneumonia | 51 (48.1) | 28 (47.5) | 23 (48.9) |
| Sepsis or septic shock | 47 (44.3) | 27 (45.8) | 20 (42.6) |
| SOFA score at the onset of infection | 5.0 (3.0–8.0) | 5.0 (3.0–7.0) | 6.0 (3.5–8.0) |
| Vasoactive drugs | 40 (37.7) | 22 (37.3) | 18 (38.3) |
| WBC count at randomisation (/mm3)b | 10,860 (8352 −15,825) | 12,375 (9162–17,137) | 9025.0 (6935–13,470) |
| Creatinine at randomization (mg/dL)c | 1.3 (0.8–2.0) | 1.2 (0.8–2.0) | 1.3 (0.9–2.0) |
| C-reactive protein at the onset of infection (mg/L)d | 119.6 (64.7–216.3) | 103.3 (56.6–190.0) | 147.9 (75.3–265.9) |
|
C-reactive protein at randomization (mg/L)e |
72.9 (28.8–156.1) | 74.6 (24.9–128.2) | 70.7 (39.5–185.1) |
| Mean arterial pressure at randomization (mmHg) | 88.5 (± 14.4) | 88.1 (± 13.8) | 89.1 (± 15.2) |
| Temperature at randomization (°C) | 36.4 (36.0–36.7) | 36.4 (36.0–36.8) | 36.4 (36.0–36.7) |
| Heart rate (beats per minute) | 91.6 (± 16.7) | 94.1 (± 17.1) | 88.5 (± 15.9) |
| Respiratory frequency (breaths per minute) | 20.0 (17.3–23.8) | 20.0 (16.5–24.5) | 20.0 (18.0–22.0) |
| Peripheral O2 saturation (%) | 96.5 (94.0–98.0) | 97.0 (94.0–98.5) | 96.0 (94.0–97.0) |
| Mechanical ventilation | 83 (78.3) | 48 (81.4) | 35 (74.5) |
| Antibiotic therapy | |||
| Appropriate empirical therapy | 50 (47.2) | 26 (44.1) | 24 (51.1) |
| Combination therapy | 27 (25.5) | 14 (23.7) | 13 (27.7) |
| Microbiology | |||
| Enterobacterales | 67 (63.2) | 34 (57.6) | 33 (70.2) |
| Carbapenem-resistant Enterobacteralesf | 42 (39.6) | 23 (39.0) | 19 (40.4) |
|
3rd and 4th Generation-resistant Enterobacteralesg |
25 (23.6) | 11 (18.6) | 14 (29.8) |
| Pseudomonas aeruginosa | 18 (17.0) | 12 (20.3) | 6 (12.8) |
|
Carbapenem-resistant Pseudomonas aeruginosa |
13 (12.3) | 11 (18.6) | 2 (4.3) |
|
3rd or 4th G-resistant Pseudomonas aeruginosa |
5 (4.7) | 1 (1.7) | 4 (8.5) |
| Acinetobacter baumannii | 29 (27.4) | 19 (32.2) | 10 (21.3) |
|
Carbapenem-resistant Acinetobacter baumannii |
27 (25.5) | 18 (30.5) | 9 (19.2) |
|
Carbapenem-susceptible Acinetobacter baumannii |
2 (1.9) | 1 (1.7) | 1 (2.1) |
| Polymicrobial infections | 15 (14.2) | 11 (18.6) | 4 (8.5) |
| Concomitant infection in another site | 20 (18.9) | 11 (18.6) | 9 (19.2) |
Data presented as n (%), mean (± standard deviation) or median (Interquartile range p25–p75)
SOFA sequential organ failure assessment, WBC white blood count, G generation
aTotal (n = 102), 7-day group (n = 57), 14-day group (n = 45)
bTotal (n = 100), 7-day group (n = 56), 14-day group (n = 44)
cTotal (n = 90), 7-day group (n = 51), 14-day group (n = 39)
dTotal (n = 63), 7-day group (n = 38), 14-day group (n = 25)
eTotal (n = 64), 7-day group (n = 38), 14-day group (n = 26)
fKlebsiella pneumoniae (total 36, 18 on 7-day group and 18 on 14-day group), Serratia marcescens (total 5, 3 on 7-day group and 2 on 14-day group) and Klebsiella oxytoca (1 on 7-day group)
gKlebsiella pneumoniae (total 15, 7 on 7-day group and 8 on 14-day group), Escherichia coli (total 4, 1 on 7-day group and 3 on 14-day group), Klebsiella oxytoca (total 2, 1 on 7-day group and 1 on 14-day group), Proteus mirabilis (total 2, 1 on 7-day group and 1 on 14-day group) and Morganella morganii (1 on 14-day group)