Table 1.
Characteristics of Patients at Baseline in the Modified Intention-to-Treat Population
| Characteristic | Daptomycin Plus Fosfomycin (n = 74) |
Daptomycin Alone (n = 81) |
|---|---|---|
| Age, y, median (IQR) | 74.0 (60.8–80.8) | 72 (62.0–80.0) |
| Male sex | 48 (64.9) | 56 (69.1) |
| Charlson comorbidity index, median (IQR)a | 3 (2–5) | 4 (2–5.8) |
| Diabetes mellitusb | 29 (30.3) | 34 (41.9) |
| Diabetes mellitus with end organ damageb | 13 (17.6) | 18 (22.2) |
| Chronic kidney diseaseb | 19 (25.7) | 35 (43) |
| Congestive heart failureb | 13 (17.6) | 19 (23.4) |
| Malignancyb | 18 (24.3) | 16 (19.7) |
| Pitt score, mean (SD)c | 1.15 (1.7) | 1.22 (2.0) |
| Implants | 20 (27.0) | 27 (33.3) |
| Orthopedic | 11 (14.9) | 13 (16.0) |
| Pacemaker | 8 (10.8) | 4 (4.9) |
| Previous antibiotic therapyd | 59 (79.7) | 65 (80.2) |
| Acquisition | ||
| Community-acquired | 7 (9.4) | 4 (4.9) |
| Nosocomial infection | 36 (48.6) | 35 (43.2) |
| Healthcare-associated | 31 (41.8) | 42 (51.8) |
| Main source of infection | ||
| Intravascular catheter | 31 (41.9) | 39 (48.1) |
| Skin and soft tissue infection | 10 (13.5) | 19 (23.5) |
| Surgical site infection | 7 (9.5) | 4 (4.9) |
| Urinary tract infection | 6 (8.1) | 3 (3.7) |
| Unknown source | 14 (18.9) | 8 (9.9) |
| Other | 6 (7.4) | 8 (9.9) |
| Echocardiography | 53 (71.6) | 59 (72.8) |
| Endocarditise | 9 (12.2) | 9 (11.1) |
| Days of therapy, median (IQR) | 14 (11–21) | 14 (10–18.5) |
Data are presented as no. (%) unless otherwise indicated.
Abbreviations: IQR, interquartile range; SD, standard deviation.
aProvides a 10-year mortality risk, based on weighted comorbid conditions.
bBased on the definitions within the Charlson comorbidity index assessment.
cProvides a measure of in-hospital mortality risk in patients with bloodstream infection based on clinical variables.
dBased on administration of any antibiotic in the 10 days prior to randomization.
eBased on assessment at test-of-cure visit according to modified Duke criteria [27].