Table 1.
PP population | ITT population | |||||
---|---|---|---|---|---|---|
Characteristic | All patients (N=1,024) | Moxifloxacin (N=505) | Comparators (N=519) | All patients (N=1,229) | Moxifloxacin (N=609) | Comparators (N=620) |
Gender, male, n (%) | 673 (65.7) | 330 (65.3) | 343 (66.1) | 807 (65.7) | 396 (65.0) | 411 (66.3) |
Mean age±SD, y | 46.7±18.4 | 46.3±18.3 | 47.0±18.6 | 47.6±18.7 | 47.6±18.7 | 47.7±18.6 |
Age ≥65 y, n (%) | 208 (20.3) | 94 (18.6) | 114 (22.0) | 269 (21.9) | 128 (21.0) | 141 (22.7) |
Mean BMI, kg/m2 (SD) | 25.7±4.9 | 25.9±4.8 | 25.5±5.0 | 25.9±5.1 | 26.2±5.1 | 25.7±5.1 |
Coexisting illnesses, n (%) | 700 (68.4) | 353 (69.9) | 347 (66.9) | 872 (71.0) | 443 (72.7) | 429 (69.2) |
Origin of infection, community-acquired, n (%) | 983 (96.0) | 486 (96.2) | 497 (95.8) | 1,174 (95.5) | 584 (95.9) | 590 (95.2) |
Mean duration of symptoms, d (SD) | 4.2±2.5 | 4.2±2.7 | 4.1±2.3 | 4.2±2.6 | 4.3±2.6 | 4.2±2.5 |
>2 d, n (%) | 881 (86.0) | 433 (85.7) | 448 (86.3) | 1,057 (86.0) | 521 (85.6) | 536 (86.5) |
Previous antibiotic therapy*, n (%) | 348 (34.0) | 167 (33.1) | 181 (34.9) | 463 (37.7) | 223 (36.6) | 240 (38.7) |
Mean core temperature, °C (SD) | 38.5±0.92 | 38.5±0.90 | 38.5±0.94 | 38.5±0.93 | 38.5±0.92 | 38.5±0.94 |
Mean WBC, (×109/L (SD) | 13.4±5.2 | 13.4±5.1 | 13.4±5.4 | 13.4±5.5 | 13.5±5.7 | 13.4±5.4 |
Mean C-reactive protein, mg/dL (SD) | 19.8±18.3 | 20.2±17.7 | 19.5±18.8 | 20.2±18.7 | 20.9±19.2 | 19.4±18.2 |
Mean APACHE II score (SD) | 6.9±5.0 | 6.9±4.7 | 6.9±5.2 | 7.0±5.0 | 7.1±4.8 | 6.9±5.2 |
Anatomic site of infection, n (%) | ||||||
Gallbladder and biliary tract | 55 (5.4) | 26 (5.1) | 29 (5.6) | 63 (5.1) | 29 (4.8) | 34 (5.5) |
Stomach or duodenum | 189 (18.5) | 91 (18.0) | 98 (18.9) | 228 (18.6) | 116 (19.0) | 112 (18.1) |
Appendix | 534 (52.1) | 269 (53.3) | 265 (51.1) | 621 (50.5) | 308 (50.6) | 313 (50.5) |
Large bowel | 166 (16.2) | 86 (17.0) | 80 (15.4) | 213 (17.3) | 107 (17.6) | 106 (17.1) |
Small bowel | 71 (6.9) | 31 (6.1) | 40 (7.7) | 90 (7.3) | 43 (7.1) | 47 (7.6) |
Others | 5 (0.5) | 1 (0.2) | 4 (0.8) | 8 (0.7) | 4 (0.7) | 4 (0.6) |
Unknown | 4 (0.4) | 1 (0.2) | 3 (0.6) | 6 (0.5) | 2 (0.3) | 4 (0.6) |
Polymicrobial infection, n (%) | 629 (61.4) | 319 (63.2) | 310 (59.7) | 741 (60.3) | 381 (62.6) | 360 (58.1) |
Bacteremia, n (%) | 29 (2.8) | 15 (3.0) | 14 (2.7) | 37 (3.0) | 22 (3.6) | 15 (2.4) |
APACHE=Acute Physiology and Chronic Health Evaluation; BMI=body mass index; cIAI=complicated intra-abdominal infections; ITT=intent-to-treat; PP=per-protocol; SD=standard deviation; WBC=white blood cell count. *Antibiotic administered within the week preceding the start of study therapy.