Table 2.
Baseline characteristics of patients in the validated per protocol (VPP) population
| CTRX (n = 104) | ABPC/SBT (n = 108) | p-value | |
|---|---|---|---|
| Male/female, n (% male) | 55/49 (53) | 60/48 (56) | 0.78* |
| Age, y | 59.0 ± 21.6 | 63.2 ± 18.9 | 0.13 |
| Comorbidities* | |||
| Cancer | 8 (8) | 12 (11) | 0.48* |
| Hematological malignancy | 2 (2) | 0 (0) | 0.24† |
| Cardiovascular disease | 7 (7) | 12 (11) | 0.34* |
| Chronic lung disease | 21 (20) | 19 (18) | 0.73* |
| Bronchial asthma | 11 (11) | 10 (9) | 0.82* |
| COPD | 6 (6) | 6 (6) | 1.00* |
| Chronic liver disease | 1 (1) | 0 (0) | 0.49† |
| Chronic kidney disease | 2 (2) | 2 (2) | 1.00† |
| Pneumonia severity index | 66.3 ± 32.5 | 68.5 ± 26.7 | 0.60 |
| Class I, n (%) | 26 (25) | 20 (19) | 0.63‡ |
| Class II, n (%) | 35 (34) | 36 (33) | |
| Class III, n (%) | 20 (19) | 38 (35) | |
| Class IV, n (%) | 19 (18) | 11 (10) | |
| Class V, n (%) | 4 (4) | 3 (3) | |
| Performance status, n (%) | |||
| 0 | 93 (89) | 98 (91) | 0.76‡ |
| 1 | 9 (9) | 8 (7) | |
| 2 | 2 (2) | 1 (1) | |
| 3 | 0 (0) | 1 (1) | |
| 4 | 0 (0) | 0 (0) | |
| Maximum body temperature, °C | |||
| Before treatment | 38.1 ± 0.9 | 38.1 ± 1.0 | 0.77 |
| Day of visit | 38.0 ± 0.9 | 38.1 ± 1.0 | 0.77 |
| Systolic blood pressure, mmHg | 127.8 ± 20.9 | 132.0 ± 24.4 | 0.18 |
| Diastolic blood pressure, mmHg | 73.0 ± 16.2 | 73.3 ± 13.4 | 0.90 |
| Pulse rate, beats/min | 91.2 ± 17.2 | 89.2 ± 15.8 | 0.36 |
| Respiration rate, breaths/min (n) | 21.1 ± 4.9 (68) | 22.0 ± 5.3 (77) | 0.31 |
| CRP, mg/dL | 11.0 ± 7.1 | 12.5 ± 7.5 | 0.12 |
| WBC, ×103/μL | 11.7 ± 4.9 | 11.0 ± 5.3 | 0.37 |
| Albumin, g/dL (n) | 3.8 ± 0.5 (103) | 3.8 ± 0.4 (106) | 0.97 |
CTRX Ceftriaxone, ABPC/SBT Ampicillin/sulbactam, CRP C-reactive protein, WBC White blood cell. Data are presented as mean ± standard deviation (SD) for continuous variables and number (%) for categorical variables. Comparisons were conducted using Student’s t-test unless otherwise indicated. *Chi-squared test. †Fisher exact test. ‡Mann–Whitney U test