Table 1.
Demographics and Baseline Characteristics for Oritavancin-Treated Patients in the CHROME Registry and SOLO Clinical Program
| Characteristica | CHROME (n = 112 patients) | Pooled SOLOb (n = 978) |
|---|---|---|
| Age, y | ||
| Mean (SD) | 58.6 (17.0) | 45.6 (13.8) |
| Median | 60.0 | 46.0 |
| Range | 18 – 96 | 18 – 89 |
| No. (%) age ≥65 y | 44 (39.3) | 86 (8.8) |
| Sex, % | ||
| Male | 53.6 | 65.3 |
| Female | 46.4 | 34.7 |
| Race (n = 108), % | ||
| White | 91.7 | 64.4 |
| Body weight (n = 111), kg | ||
| Mean (SD) | 98.4 (29.4) | 79.0 (22.7) |
| Median | 97.5 | 75 |
| Range | 48 – 223 | 35 – 200 |
| Body mass index (n = 109), kg/m2 | ||
| Mean (SD) | 33.0 (9.6) | 27.7 (7.6) |
| Median | 31.6 | 26.2 |
| Range | 16–65 | 15–74 |
| Meets SIRS criteria, No. (%)c | 4/112 (3.6) | 169 (17.3) |
| Temperature ≥38oC | 0/104 (0) | 186/978 (19.0) |
| WBC count >12 000 mm3 | 11/52 (21.2) | 216/887 (24.4) |
| Common infection management procedures, % (n/N) | 29 (33/112) | 14.1 (138/978) |
| Incision and drainage of abscess | 63.6 (21/33) | 58.0 (80/138) |
| Deep tissue surgical debridement | 21.2 (7/33) | 20.3 (28/138)d |
| Superficial surgical debridement | 15.2 (5/33) | |
| Hospitalized, % (n/N) | Prior to receipt of oritavancin: 10.7 (12/112)e | Study postrandomization: 60 (586/978)e |
| Patients receiving antibiotics prior to oritavancin, % (n/N) | 70.5 (79/112)f | 19.6 (192/978)f |
| Concomitant medical conditions, % | ||
| Vascular disorders | 55.4 | |
| Hypertension | 44.6 | |
| Diabetes | 37.5 | 14.2 |
| Intravenous drug use | ND | 29.2 |
| Hyperlipidemia | 25.1 | |
| Neoplastic disease | 17.9 | |
| Microbiology | ||
| Baseline infection site culture recovery rate,g % (n/N) | 64.8 (46/71) | 63.4 (620/978) |
| Confirmed gram-positive pathogen at baseline,h % (n/N) | 96.0 (48/50i) | 53.3 (529/992 [ITT]) |
| Staphylococcus aureus | 77.1 (37/48) | 89.2 (472/529) |
| MRSA, % (n/N) | 78.4 (29/37) | 38.6 (204/529) |
| MSSA, % (n/N) | 21.6 (8/37) | 50.7 (268/529) |
| Infection type, No. (%) | ||
| Cellulitis | 67.0 (75) | 39.6 (387) |
| Cutaneous abscess | 21.4 (24) | 31.5 (288) |
| Wound infection | 4.5 (5) | 28.9 (283) |
| Otherj | 7.1 (8) | NA |
Abbreviations: CHROME, Clinical and Historic Registry and Orbactiv Medical Evaluation; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-sensitive Staphylococcus aureus; SIRS, systemic inflammatory response syndrome; WBC, white blood cell.
aCharacteristic applies to 112 patients unless otherwise stated.
bReference 3.
cSystemic inflammatory response syndrome is defined as 2 of the following: temperature >38°C, pulse >90 beats per minute, respiratory rate >20 breaths per minute, white blood cell count >12 000 mm3 or <4000 mm3, or >10% bandemia.
dFor SOLO patients, the infection management procedure most closely related to deep tissue surgical debridement was major surgical debridement under general anesthesia.
eFor CHROME, hospitalization refers to the care necessary to treat the lesion within 28 days prior to oritavancin administration; for the pooled SOLO population, hospitalization refers to those who received some of their postrandomization study drug treatment in an inpatient setting; this does not infer that these patients were hospitalized prior to receipt of oritavancin.
fCHROME, within 28 days prior to oritavancin; SOLO, within 14 days prior to screening.
gSeventy-one patients with infection sites cultured.
hOf all pathogens identified.
iFifty total pathogens recovered from 46 cultured sites; 48 were gram-positive.
jOther infection type included chronic osteomyelitis (2), bursitis (1), tenosynovitis (1), diabetic foot (1), bacterial arthritis (1), lymphadenitis (1), and nonspecific impaired healing (1).