Table 1.
Demographics and Baseline Patient and Disease Characteristics in the Safety Population
| Characteristica | Dalbavancin (n = 70) |
Standard of Care (n = 10) |
|---|---|---|
| Age, mean (SD; range), y | 49.2 (13.3; 26–79) | 54.4 (15.3; 29–79) |
| Male sexb | 59 (84.3) | 5 (50.0) |
| Race | ||
| White | 70 (100) | 10 (100) |
| Ethnicity | ||
| Not Hispanic/Latino | 70 (100) | 10 (100) |
| Body mass index, kg/m2 | ||
| Mean (SD) | 26.1 (5.1) | 30.7 (7.4) |
| Median (min, max) | 24.7 (18.6, 40.1) | 33.8 (21.6, 40.3) |
| Diabetesc | 10 (14.3) | 5 (50.0) |
| Predisposing factors at site of osteomyelitis | ||
| Prior fracture and surgical repair | 33 (47.1) | 4 (40.0) |
| Prior fracture | 2 (2.9) | 0 |
| Surgical intervention | ||
| Debridement and open biopsy | 70 (100) | 10 (100) |
| Vacuum-assisted closure of wound | 8 (11.4) | 3 (30) |
| Skin graft | 1 (1.4) | 1 (10) |
| Aztreonam use | 8 (11.4) | 1 (10) |
| Site of osteomyelitisd | Tibia: 27 (38.6) Foot: 17 (24.3) Femur: 11 (15.7) Humerus: 4 (5.7) Hand: 4 (5.7) Ulna: 1 (1.4) Fibula: 2 (2.9) Pelvic bone: 1 (1.4) Other: 3 (4.3) |
Tibia: 2 (20) Foot: 2 (20) Femur: 4 (40) Fibula: 1 (10) Pelvic bone: 1 (10) |
| Baseline diabetic foot infection | 4 (5.7) | 1 (10) |
| Baseline CRP, mg/Le | ||
| Mean | 43.9 | 20.4 |
| Median | 24 | 18 |
| Baseline ESR, mm/hf | ||
| Mean | 33.2 | 30.6 |
| Median | 34 | 24 |
| Baseline bacteremia | ||
| MSSA | 2 (3) | 0 |
| Coagulase-negative staphylococci | 2 (3) | 1 (10) |
| Baseline pathogen in boneg | 65 (92.9) | 10 (100) |
| Staphylococcus aureus | 42 (60) | 6 (60) |
| MSSA | 38 (54.3) | 5 (50) |
| MRSA | 4 (5.7) | 1 (10) |
| Coagulase-negative staphylococci | ||
| Staphylococcus epidermidis | 6 (8.6) | 2 (20) |
| Staphylococcus haemolyticus | 4 (5.7) | 0 |
| Staphylococcus hominis | 2 (2.9) | 0 |
| Staphylococcus pasteuri | 1 (1.4) | 0 |
| Staphylococcus simulans | 1 (1.4) | 0 |
| Enterococci | ||
| Enterococcus faecalis | 7 (10) | 1 (10) |
| Enterococcus faecium | 1 (1.4) | 0 |
| Anaerobes | 9 (12.9) | 0 |
| Streptococci | ||
| Streptococcus agalactiae | 1 (1.4) | 1 (10) |
| Streptococcus dysgalactiae | 1 (1.4) | 0 |
| Streptococcus pyogenes | 1 (1.4) | 0 |
| Other gram-positive pathogens | ||
| Corynebacterium striatum | 2 (2.9) | 1 (10) |
| Aerococcus viridans | 1 (1.4) | 0 |
| Globicatella species | 1 (1.4) | 0 |
| Micrococcus luteus | 1 (1.4) | 0 |
| Mixed (gram-positives and aerobic gram-negatives) | 11 (15.7) | 2 (20) |
| Gram-negative pathogens onlyh | 3 (4.3) | 2 (20) |
| No growthi | 5 (7.1) | 0 |
| Baseline bone histology | ||
| Acute inflammatory cells | 56 (80) | 8 (80) |
| Necrotic bone | 43 (61.4) | 6 (60) |
| Edema | 11 (15.7) | 4 (40) |
| Granulations | 8 (11.4) | 1 (10) |
| Vascular congestion | 4 (5.7) | 0 |
Abbreviations: CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; ITT, intent-to-treat; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible S. aureus; SOC, standard of care.
aData are presented as No. (%) unless otherwise specified.
b P = .024.
c P = .017.
d“Other” sites include patella (n = 1), clavicle (n = 1), finger (n = 1).
eCRP normal range = 0–6 mg/L.
fESR normal range = 1–10 mm/h.
gCategories are not mutually exclusive.
hThree patients in the dalbavancin arm and 2 patients in the SOC arm were premature discontinuations from study drug due to only gram-negative pathogens isolated from bone culture.
iFive patients in the dalbavancin arm had no growth on bone biopsy; histology results showed necrotic bone in 3/5 (60%) and acute inflammatory cells in 2/5 (40%).