Table 1.
Baseline demographics and clinical characteristics of the primary analysis sample
| Characteristic | Daptomycin (n = 118) | Vancomycin (n = 106) |
|---|---|---|
| Demographics | ||
| Male, n (%) | 64 (54.2) | 57 (53.8) |
| Age, y, mean (SD) | 47.2 (15.2) | 50.0 (13.5) |
| Weight, kg, mean (SD) | 97.1 (29.8) | 97.4 (30.4) |
| BMI, mean (SD) | 33.2 (10.3) | 34.2 (11.7) |
| Clinical characteristics | ||
| Hospitalizations in preceding year, n (%) | 61 (51.7) | 49 (46.2) |
| Patients with cSSSI in preceding 6 months, n (%) | 36 (30.5) | 37 (34.9) |
| Charlson comorbidity score, mean (SD) | 1.1 (1.6) | 1.1 (1.3) |
| Patients with diabetes, n (%) | 34 (28.8) | 37 (34.9) |
| SIRS symptoms, n (%) | ||
| Temperature > 38 °C or > 100.4 °F | 19 (16.1) | 12 (11.3) |
| Heart rate > 90 beats/minute | 54 (45.8) | 43 (40.6) |
| Tachypnea (> 20 breaths/minute) | 12 (10.2) | 6 (5.7) |
| Blood pressure < 90/50 mmHg | 5 (4.2) | 1 (0.9) |
| WBC count > 12 × 109/L | 61 (51.7) | 41 (38.7) |
| Blood urea nitrogen > 8.9 mmol/L | 12 (10.2) | 6 (5.7) |
| Creatinine > 132.6 μmol/L | 12 (10.2) | 9 (8.5) |
| Patient-reported pain score, mean (SD) | 6.6 (3.0) | 6.9 (3.2) |
| Vancomycin use at enrollment or within 48 h before randomization, n (%) | 65 (55.1) | 50 (47.1) |
| Baseline blood culture, n (%) | 82 (69.5) | 76 (71.7) |
| Gram-negative infection, n (%)a | 11 (16.7) | 7 (10.8) |
| cSSSI diagnosis, n (%) | ||
| Complicated cellulitisb | 81 (68.6) | 65 (61.3) |
| Major cutaneous abscess | 45 (38.1) | 46 (43.4) |
| Wound infection | 18 (15.3) | 16 (15.1) |
| Erysipelas | 0 (0) | 0 (0) |
| Diabetic ulcer | 2 (1.7) | 5 (4.7) |
| Nondiabetic ulcer (stasis ulcer/decubitus ulcer) | 2 (1.7) | 3 (2.8) |
| Bite wound | 1 (0.9) | 1 (0.9) |
| Burn wound | 0 (0) | 0 (0) |
| Otherc | 2 (1.7) | 3 (2.8) |
BMI body mass index, cSSSI complicated skin and skin structure infection, SD standard deviation, SIRS systemic inflammatory response syndrome, WBC white blood cell
aBased on the number of patients with primary skin infection lesion culture obtained at baseline (daptomycin, n = 66; vancomycin, n = 65)
bDefined as cellulitis that requires hospitalization and treatment with IV antibiotics suspected or documented to be caused by MRSA
c“Other” infection sites include groin, axillae, breast, back, suprapubic region, genitalia, anterior perineum, face, hand, and preseptal region