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Table 1 Baseline demographics and clinical characteristics of the primary analysis sample

From: An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection

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)

  1. BMI body mass index, cSSSI complicated skin and skin structure infection, SD standard deviation, SIRS systemic inflammatory response syndrome, WBC white blood cell
  2. aBased on the number of patients with primary skin infection lesion culture obtained at baseline (daptomycin, n = 66; vancomycin, n = 65)
  3. bDefined as cellulitis that requires hospitalization and treatment with IV antibiotics suspected or documented to be caused by MRSA
  4. c“Other” infection sites include groin, axillae, breast, back, suprapubic region, genitalia, anterior perineum, face, hand, and preseptal region