TABLE 1.
Baseline demographics, clinical characteristics, and outcomes of the efficacy population
| Parameter | Value for group |
||
|---|---|---|---|
| Overall (n = 126) | Monotherapy (n = 89) | Combination therapy (n = 37) | |
| Demographics | |||
| Median age (yr) (IQR) | 59 (45.5–66.8) | 59 (48–67) | 57 (45–66.5) |
| No. of male patients (%) | 70 (55.6) | 50 (56.2) | 20 (54.1) |
| No. of patients of race (%) | |||
| African American | 86 (68.3) | 62 (69.7) | 24 (64.9) |
| Caucasian | 34 (27.0) | 21 (23.6) | 13 (35.1) |
| Hispanic/Latino | 1 (0.8) | 1 (1.1) | 0 |
| Other | 5 (4.0) | 5 (5.6) | 0 |
| No. of patients in hospital system (%) | |||
| Detroit Medical Center | 83 (65.9) | 52 (58.4) | 31 (83.8) |
| UF Health-Shands Hospital | 30 (23.8) | 26 (29.2) | 4 (10.8) |
| Henry Ford Hospital | 13 (10.3) | 11 (12.4) | 2 (5.4) |
| Comorbidities and past medical history | |||
| No. of patients with comorbidity or past medical history (%) | |||
| Prior antibiotics (90 days) | 33 (26.2) | 24 (27.0) | 9 (24.3) |
| Prior MRSA infection (1 yr) | 20 (15.9) | 14 (15.7) | 6 (16.2) |
| Obesity | 48 (38.1) | 37 (41.6) | 11 (29.7) |
| Diabetes mellitus | 47 (37.3) | 34 (38.2) | 13 (35.1) |
| Chronic kidney disease | 34 (27.0) | 25 (28.1) | 9 (24.3) |
| Chronic hemodialysis | 26 (20.6) | 19 (21.3) | 7 (18.9) |
| Liver disease | 20 (15.9) | 13 (14.6) | 7 (18.9) |
| Intravenous drug user | 24 (19.0) | 14 (15.7) | 10 (27.0) |
| Malignancy | 7 (5.6) | 4 (4.5) | 3 (8.1) |
| HIV/AIDS | 8 (6.3) | 3 (3.4) | 5 (13.5) |
| Neutropeniaa | 3 (2.4) | 2 (2.2) | 1 (2.7) |
| Median Charlson comorbidity index (IQR) | 3 (2–5) | 3 (2–5) | 3 (2–5) |
| Clinical characteristics | |||
| No. of patients in intensive care unit (%)b | 45 (35.7) | 31 (34.8) | 14 (37.8) |
| Median APACHE II score (IQR)b | 16 (12–22) | 16 (12–22) | 16 (13–22) |
| No. (%) of patients with: | |||
| Lower respiratory tract source | 41 (32.5) | 30 (33.7) | 11 (29.7) |
| Infective endocarditis source | 31 (24.6) | 20 (22.5) | 11 (29.7) |
| Bone/joint source | 26 (20.6) | 20 (22.5) | 6 (16.2) |
| Intravenous catheter source | 20 (15.9) | 16 (18.0) | 4 (10.8) |
| Skin/soft tissue source | 11 (8.7) | 9 (10.1) | 2 (5.4) |
| Other source | 22 (17.5) | 14 (15.7) | 8 (21.6) |
| Polymicrobial BSI | 10 (7.9) | 6 (6.7) | 4 (10.8) |
| Vancomycin-susceptible strainc | 125 (99.2) | 88 (98.9) | 37 (100.0) |
| Daptomycin-susceptible strainc,d | 116 (96.7) | 80 (96.4) | 36 (97.3) |
| Ceftaroline-susceptible straine | 94 (96.9) | 70 (95.9) | 24 (100.0) |
| Treatment information | |||
| No. (%) of patients with: | |||
| Infectious diseases consultf | 113 (93.4) | 79 (91.9) | 34 (97.1) |
| Source control pursuedg | 42 (34.7) | 28 (32.9) | 14 (38.9) |
| Prior directed therapy with vancomycin | 107 (84.9) | 74 (83.1) | 33 (89.2) |
| Prior directed therapy with daptomycin | 48 (38.1) | 22 (24.7) | 26 (70.3) |
| Ceftaroline dosing frequency | |||
| Every 8 h | 66 (52.4) | 52 (58.4) | 14 (37.8) |
| Every 12 h | 54 (42.9) | 33 (37.1) | 21 (56.8) |
| Every 24 h | 6 (4.8) | 4 (4.5) | 2 (5.4) |
| Ceftaroline dose | |||
| 600 mg | 76 (60.3) | 55 (61.8) | 21 (56.8) |
| 400 mg | 19 (15.1) | 14 (15.7) | 5 (13.5) |
| 300 mg | 11 (8.7) | 8 (9.0) | 3 (8.1) |
| 200 mg | 20 (15.9) | 12 (13.5) | 8 (21.6) |
| Median ceftaroline inpatient duration (days) (IQR) | 13 (5–21) | 13 (5–22) | 14 (4–17) |
| No. (%) of patients receiving combination therapy with: | |||
| Daptomycin | 28 (22.2) | 28 (75.7) | |
| Vancomycin | 3 (2.4) | 3 (8.1) | |
| Gentamicin | 3 (2.4) | 3 (8.1) | |
| Rifampin | 5 (4.0) | 5 (13.5) | |
| Outcomes | |||
| No. of patients achieving clinical success (%) | 86 (68.3) | 62 (69.7) | 24 (64.9) |
| No. of patients with in-hospital mortality (%) | 28 (22.2) | 17 (19.1) | 11 (29.7) |
| No. of patients with cleared BSI on ceftaroline (%) | 115 (91.3) | 79 (88.8) | 36 (97.3) |
| Median BSI duration post-ceftaroline initiation (days) (IQR) | 3 (1–4) | 2 (1–4) | 3 (1.5–5) |
| Median length of stay post-ceftaroline initiation (days) (IQR) | 12 (8–20) | 12 (8–18) | 15 (8.5–22.5) |
Defined as an absolute neutrophil count of <500 cells/mm3 at ceftaroline initiation.
At the time of the index culture.
Susceptibility determined by Microscan, Vitek 2, BD Phoenix, or Etest.
Daptomycin susceptibility were available for 120, 83, and 37 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.
Ceftaroline susceptibility was determined by Etest for 97, 73, and 24 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.
Infectious diseases consult status known for 121, 86, and 35 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.
Pursuit of source control known for 121, 85, and 36 patients in the efficacy population and the monotherapy and combination therapy subgroups, respectively.