TABLE 1.
Baseline demographics, clinical characteristics, and microbiology in the ITT populationa
| Characteristicb | 200 mg tedizolid once daily | 600 mg linezolid twice daily |
|---|---|---|
| n | 664 | 669 |
| Age | 44.5 (17–86) | 44.0 (15–100) |
| Median (range) (yr) | ||
| ≥65 | 72 (10.8) | 59 (8.8) |
| Male sex | 429 (64.6) | 412 (61.6) |
| Region of enrollment | ||
| USA/Canada | 426 (64.2) | 426 (63.7) |
| Europe | 165 (24.8) | 166 (24.8) |
| Other region | 73 (11.0) | 77 (11.5) |
| Temperature ≥ 38°C (fever) | 155 (23.3) | 157 (23.5) |
| WBC count ≥ 10,000 cells/mm3 or <4,000 cells/mm3 | 140 (21.1) | 133 (19.9) |
| SIRS | 163 (24.5) | 128 (19.1) |
| Lymphadenopathy | 524 (78.9) | 524 (78.3) |
| >10% immature neutrophils | 76 (11.4) | 56 (8.4) |
| ≥1 Gram-positive pathogen from baseline primary infection site or blood culturec | ||
| Staphylococcus aureusd | 329 (81.0) | 342 (83.0) |
| MRSA | 141 (34.7) | 146 (35.4) |
| USA300 strain | 127 (90.1) | 110 (75.3) |
| MSSA | 188 (46.3) | 198 (48.1) |
| PVL-positive S. aureus | 190 (46.8) | 181 (43.9) |
| Streptococcus pyogenes | 33 (8.1) | 20 (4.9) |
| Streptococcus anginosus group | 30 (7.4) | 28 (6.8) |
| Bacteremia | 11 (1.7) | 16 (2.4) |
| Comorbidities | ||
| Obesity | 200 (30.1) | 232 (34.7) |
| History of diabetes mellitus | 58 (8.7) | 67 (10.0) |
| Hepatic impairment/disease | 14 (2.1) | 12 (1.8) |
| Renal impairment (moderate/severe) | 20 (3.0) | 29 (4.3) |
| HIV positive | 13 (2.0) | 8 (1.2) |
| Hepatitis C | 165 (24.8) | 194 (29.0) |
| Concurrent secondary ABSSSI lesion | 96 (14.5) | 90 (13.5) |
| Risk factors | ||
| Current/recent i.v. drug use | 183 (27.6) | 206 (30.8) |
| Poor living conditions | 40 (6.0) | 34 (5.1) |
| Prior ABSSSI lesion | 146 (22.0) | 144 (21.5) |
| Type of ABSSSI | ||
| Cellulitis/erysipelas | 301 (45.3) | 307 (45.9) |
| Major cutaneous abscess | 168 (25.3) | 166 (24.8) |
| Wound infection | 195 (29.4) | 196 (29.3) |
| Anatomical location of ABSSSI | ||
| Lower extremity | 270 (40.7) | 282 (42.2) |
| Upper extremity | 226 (34.0) | 226 (33.8) |
| Groin/buttocks/back | 93 (14.0) | 93 (13.9) |
| Chest/abdomen | 39 (5.9) | 33 (4.9) |
| Head/neck | 36 (5.4) | 35 (5.2) |
| Lesion surface area (cm3) | ||
| Mean (range) | 347.8 (22.5–5,572.8) | 347.8 (27.0–5,220.0) |
| >300 | 228 (34.4) | 220 (32.9) |
a
Data are presented as no. (%) unless otherwise stated. ITT, intent-to-treat.
b
WBC, white blood cell; SIRS, systemic inflammatory response syndrome; MRSA, methicillin-resistant S. aureus; MSSA, methicillin-susceptible S. aureus; PVL, Panton-Valentine leukocidin; HIV, human immunodeficiency virus; ABSSSI, acute bacterial skin and skin structure infection.
c
The number of patients fitting this criterion were 406 in the tedizolid group and 412 in the linezolid group.
d
MRSA and MSSA totals may not add up to 100% because of a lack of susceptibility data for all isolates; one patient in ESTABLISH-1 may have had both MRSA and MSSA.