Table 2.
Demographic and Baseline Characteristics for Patients in the Phase III ABSSSI Studies
| OASIS-1 and OASIS-2 | |||
|---|---|---|---|
| Characteristic | Omadacycline (n = 691) | Linezolid (n = 689) | All Patients (n = 1380) |
| Age, years | |||
| Mean (SD) | 44.7 (14.2) | 45.5 (14.2) | 45.1 (14.2) |
| Min, max | 18, 88 | 18, 90 | 18, 90 |
| Sex | |||
| Male | 445 (64.4) | 433 (62.8) | 878 (63.6) |
| Race | |||
| White | 621 (89.9) | 641 (93.0) | 1262 (91.4) |
| Ethnicity | |||
| Hispanic or Latino | 238 (34.4) | 247 (35.8) | 485 (35.1) |
| Not Hispanic or Latino | 449 (65.0) | 440 (63.9) | 889 (64.4) |
| Not reported/unknown | 4 (0.6) | 2 (0.3) | 6 (0.4) |
| Region | |||
| United States | 570 (82.5) | 570 (82.7) | 1140 (82.6) |
| Non–United States | 121 (17.5) | 119 (17.3) | 240 (17.4) |
| European Uniona | 85 (12.3) | 88 (12.8) | 173 (12.5) |
| BMI (kg/m2)b | |||
| <25 | 260 (37.6) | 245 (35.6) | 505 (36.6) |
| 25–30 | 221 (32.0) | 243 (35.3) | 464 (33.6) |
| >30 | 210 (30.4) | 200 (29.1) | 410 (29.7) |
| Creatinine clearance | |||
| >89 mL/min | 603 (87.6) | 612 (89.5) | 1215 (88.6) |
| 60–89 mL/min | 64 (9.3) | 51 (7.5) | 115 (8.4) |
| <60 mL/min | 21 (3.1) | 21 (3.1) | 42 (3.1) |
| Type of primary infection | |||
| N (mITT population) | 676 | 671 | 1347 |
| Wound infection | 312 (46.2) | 318 (47.4) | 630 (46.8) |
| Cellulitis/erysipelas | 209 (30.9) | 202 (30.1) | 411 (30.5) |
| Major abscess | 155 (22.9) | 151 (22.5) | 306 (22.7) |
| Pathogenc | |||
| N (micro-mITT population) | 504 | 514 | 1018 |
| Gram-positive aerobes | 490 (97.2) | 497 (96.7) | 987 (97.0) |
| Staphylococcus aureus | 376 (74.6) | 384 (74.7) | 760 (74.7) |
| MRSA | 173 (34.3) | 157 (30.5) | 330 (32.4) |
| MSSA | 208 (41.3) | 232 (45.1) | 440 (43.2) |
| Streptococcus pyogenes | 40 (7.9) | 34 (6.6) | 74 (7.3) |
| Streptococcus anginosus groupd | 104 (20.6) | 82 (16.0) | 186 (18.3) |
| Gram-positive anaerobes | 33 (6.5) | 32 (6.2) | 65 (6.4) |
| Gram-negative aerobes | 52 (10.3) | 53 (10.3) | 105 (10.3) |
| Gram-negative anaerobes | 28 (5.6) | 25 (4.9) | 53 (5.2) |
Data are presented as No. (%) and are from the safety population, unless otherwise noted. The denominator for the percentage was the number of patients who had that parameter assessed.
Abbreviations: ABSSSI, acute bacterial skin and skin structure infections; BMI, body mass index; max, maximum; min, minimum; mITT, modified intent-to-treat; MRSA, methicillin-resistant Staphylococcus aureus; MSSA, methicillin-susceptible Staphylococcus aureus; OASIS, Omadacycline in Acute Skin and Skin Structure Infections Study; SD, standard deviation.
aThe European Union data were a subset of non–United States data, not a mutually exclusive subgroup.
bThe highest BMI measured in the study was 71.3 kg/m2.
cIn each infection, >1 pathogen may have been present; therefore, numbers sum to >100%. Pathogens present in >5% of patients in the micro-mITT population (all mITT patients who had ≥1 causative pathogen) are shown.
d Streptococcus anginosus group consists of S. anginosus, S. intermedius, and S. constellatus.