Table 2.
cSSSI and disease-related characteristics at baseline (ITT and PP populations)
| ITT |
PP |
|||
|---|---|---|---|---|
| moxifloxacin (N = 426) | TZP–AMC (N = 377) | moxifloxacin (N = 361) | TZP–AMC (N = 307) | |
| cSSSI diagnosis, n (%) | ||||
| major abscess | 183 (43.0) | 169 (44.8) | 167 (46.3) | 153 (49.8) |
| diabetic foot infection | 123 (28.9) | 110 (29.2) | 110 (30.5) | 96 (31.3) |
| wound infection | 72 (16.9) | 55 (14.6) | 62 (17.2) | 47 (15.3) |
| infected ischaemic ulcer | 24 (5.6) | 18 (4.8) | 22 (6.1) | 11 (3.6) |
| other cSSSI | 4 (0.9) | 3 (0.8) | — | — |
| uSSSI or no infection | 20 (4.7) | 22 (5.8) | — | — |
| Source of infection | ||||
| community acquired, n (%) | 368 (86.4) | 345 (91.5) | 310 (85.9) | 280 (91.2) |
| hospital acquired, n (%) | 58 (13.6) | 32 (8.5) | 51 (14.1) | 27 (8.8) |
| Location of primary lesion, n (%) | ||||
| foot | 154 (36.2) | 132 (35.0) | 134 (37.1) | 110 (35.8) |
| legs | 82 (19.2) | 78 (20.7) | 57 (15.8) | 46 (15.0) |
| buttocks and genitals | 58 (13.6) | 61 (16.2) | 53 (14.7) | 55 (17.9) |
| arm | 37 (8.7) | 32 (8.5) | 35 (9.7) | 29 (9.4) |
| abdomen and groin | 39 (9.2) | 22 (5.8) | 32 (8.9) | 21 (6.8) |
| hand | 20 (4.7) | 20 (5.3) | 19 (5.3) | 19 (6.2) |
| head and neck | 22 (5.2) | 21 (5.6) | 19 (5.3) | 18 (5.9) |
| chest and back | 14 (3.3) | 11 (2.9) | 12 (3.3) | 9 (2.9) |
| Deepest plane involved, n (%) | ||||
| fascia | 153 (35.9) | 145 (38.5) | 125 (34.6) | 115 (37.5) |
| muscle | 117 (27.5) | 101 (26.8) | 97 (26.9) | 79 (25.7) |
| fat | 105 (24.6) | 78 (20.7) | 96 (26.6) | 72 (23.5) |
| bone | 20 (4.7) | 26 (6.9) | 18 (5.0) | 21 (6.8) |
| dermis | 17 (4.0) | 14 (3.7) | 14 (3.9) | 8 (2.6) |
| othera | 14 (3.3) | 13 (3.4) | 11 (3.0) | 12 (3.9) |
| Wilson score evaluationb | ||||
| mean (SD) score | 83.5 (31.3) | 81.4 (30.2) | 84.7 (32.4) | 83.3 (30.8) |
| risk class, n (%) | ||||
| I | 118 (27.7) | 116 (30.8) | 100 (27.7) | 99 (32.2) |
| II | 92 (21.6) | 65 (17.2) | 84 (23.2) | 54 (17.6) |
| III | 92 (21.6) | 87 (23.1) | 75 (20.8) | 73 (23.8) |
| IV | 124 (29.1) | 109 (28.9) | 102 (28.3) | 81 (26.4) |
| White blood cells ≥10 500 Giga/L, n (%) | 174 (40.8) | 111 (29.4) | 149 (41.3) | 97 (31.6) |
| C-reactive protein ≥0.5 mg/dL, n (%) | 378 (88.7) | 334 (88.6) | 328 (90.9) | 277 (90.2) |
| Temperature >38°C, n (%) | 385 (90.4) | 335 (88.9) | 329 (91.1) | 279 (90.9) |
| Initialc surgery, n (%) | 321 (75.4) | 298 (79.0) | 285 (78.9) | 256 (83.4) |
| Mean (SD) duration of anaesthesia (min) | 43.1 (48.9) | 38.8 (35.7) | 42.8 (49.1) | 37.6 (33.8) |
| Most common initial surgeriesc,d, n (%) | ||||
| local debridement | 99 (23.2) | 85 (22.5) | 87 (24.1) | 72 (23.5) |
| abscess drainage | 237 (55.6) | 222 (58.9) | 212 (58.7) | 199 (64.8) |
| extensive debridement | 113 (26.5) | 112 (29.7) | 97 (26.9) | 99 (32.2) |
| amputation | 58 (13.6) | 48 (12.7) | 53 (14.7) | 36 (11.7) |
Other cSSSIs in the moxifloxacin group were complicated erysipelas (n = 1), necrotizing fasciitis (n = 2) and other skin infection requiring surgery (n = 1), and in the comparator group were necrotizing fasciitis (n = 2) and other skin infection requiring surgery (n = 1).
aTendon, articulum/joint, aponeurosis and subcutaneous tissue.
bSee reference 19.
cBefore or within 48 h of initiation of study drug.
dPatients may have undergone more than one type of surgery.