Table 1.
Patients' baseline characteristics (ITT population)
| Characteristic | Delafloxacin (n = 81) | Linezolid (n = 77) | Vancomycin (n = 98) |
|---|---|---|---|
| Male, n (%) | 49 (60.5) | 52 (67.5) | 51 (52.0) |
| Age (years) | |||
| mean (SD) | 39.7 (14.26) | 44.8 (14.91) | 44.8 (15.54) |
| median | 36.0 | 47.0 | 45.0 |
| Race, n (%) | |||
| Caucasian | 63 (77.8) | 58 (75.3) | 74 (75.5) |
| black or African American | 10 (12.3) | 15 (19.5) | 15 (15.3) |
| othera | 8 (9.9) | 4 (5.2) | 9 (9.2) |
| BMI (kg/m2) | |||
| mean (SD) | 29.4 (6.47) | 29.5 (6.37) | 29.6 (6.88) |
| median | 28.3 | 29.4 | 28.5 |
| Diabetic, n (%) | 5 (6.2) | 5 (6.7) | 16 (16.3) |
| ABSSSI category, n (%) | |||
| cellulitis/erysipelas | 39 (48.1) | 32 (41.6) | 44 (44.9) |
| major cutaneous abscess | 21 (25.9) | 24 (31.2) | 28 (28.6) |
| wound infection | 19 (23.5) | 19 (24.7) | 26 (26.5) |
| burn infection | 2 (2.5) | 2 (2.6) | 0 |
| Erythema total area (cm2; digital), median (range)b | 187.9 (7.5–1555.3) | 197.4 (6.1–4658.9) | 164.6 (0.0–1503.6) |
| Induration total area (cm2; digital), median (range)b | 67.3 (0.0–907.5) | 62.2 (0.0–4103.0) | 75.1 (0.0–1429.4) |
| Prior antibacterial therapy,c n (%) | 20 (24.7) | 24 (31.2) | 28 (28.6) |
| Identified pathogens, n (%) | |||
| none | 30 (37.0) | 20 (26.0) | 31 (31.6) |
| at least one | 51 (63.0) | 57 (74.0) | 67 (68.4) |
| S. aureus | 45 (55.6) | 53 (68.8) | 61 (62.2) |
| MRSA | 34 (42.0) | 37 (48.1) | 35 (35.7) |
| MSSA | 11 (13.6) | 16 (20.8) | 26 (26.5) |
| multiple pathogens | 6 (7.4) | 15 (19.5) | 8 (8.2) |
| Positive blood culture, n (%) | 0 | 6 (7.8) | 1 (1.0) |
| Fever, n (%) | 18 (22.2) | 18 (23.4) | 29 (29.6) |
| Serum CRP (mg/L),d mean (SD) | 46.6 (70.66) | 49.3 (56.14) | 55.2 (69.70) |
| Serum IL-6 (ng/L),e mean (SD) | 11.4 (15.35) | 14.5 (15.14) | 16.6 (17.93) |
| Blood glucose (mmol/L),f mean (SD) | 5.53 (2.365) | 6.27 (3.957) | 6.32 (3.138) |
aIncluding American Indian or Alaska Native, Asian and Native Hawaiian or other Pacific Islander.
bn = 75 delafloxacin, 73 linezolid and 93 vancomycin.
cA single dose of an antibiotic potentially effective against the ABSSSI under study, taken within the 24 h before study entry.
dn = 71 delafloxacin, 71 linezolid and 92 vancomycin.
en = 71 delafloxacin, 70 linezolid and 93 vancomycin.
fSafety population; n = 63 delafloxacin, 58 linezolid and 82 vancomycin.