Table 1.
Patient demographic and baseline characteristics.
| Parameter | All Patients (Pooled ITT Population) |
Patients with Atypical Pathogens * (Pooled microITT Population) |
||
|---|---|---|---|---|
| Lefamulin (n = 646) |
Moxifloxacin (n = 643) |
Lefamulin (n = 91) |
Moxifloxacin (n = 87) |
|
| Age, y, mean (SD) | 58.9 (16.5) | 58.5 (15.7) | 54.7 (17.8) | 55.6 (17.5) |
| Age ≥ 65 y, n (%) | 268 (41.5) | 249 (38.7) | 28 (30.8) | 32 (36.8) |
| Male, n (%) | 377 (58.4) | 340 (52.9) | 53 (58.2) | 49 (56.3) |
| White, n (%) | 513 (79.4) | 509 (79.2) | 84 (92.3) | 74 (85.1) |
| PORT risk class, † n (%) | ||||
| I | 1 (0.2) | 2 (0.3) | 0 | 0 |
| II | 183 (28.3) | 190 (29.5) | 26 (28.6) | 21 (24.1) |
| III | 341 (52.8) | 334 (51.9) | 49 (53.8) | 44 (50.6) |
| IV | 116 (18.0) | 112 (17.4) | 16 (17.6) | 22 (25.3) |
| V | 5 (0.8) | 5 (0.8) | 0 | 0 |
| CURB-65 score, ‡ n (%) | ||||
| 0–2 | 610 (94.4) | 604 (93.9) | 87 (95.6) | 80 (92.0) |
| 3–5 | 36 (5.6) | 39 (6.1) | 4 (4.4) | 7 (8.0) |
|
Minor ATS severity
criteria, § n (%) |
85 (13.2) | 85 (13.2) | 15 (16.5) | 9 (10.3) |
|
Modified ATS severity
criteria, || n (%) |
53 (8.2) | 57 (8.9) | 8 (8.8) | 7 (8.0) |
| Multilobar pneumonia, n (%) | 170 (26.3) | 177 (27.5) | 20 (22.0) | 17 (19.5) |
| SIRS, n (%) | 621 (96.1) | 609 (94.7) | 89 (97.8) | 82 (94.3) |
| Bacteremic, n (%) | 13 (2.0) | 12 (1.9) | 0 | 1 (1.1) |
| Prior antibiotic use, # n (%) | 147 (22.8) | 145 (22.6) | 28 (30.8) | 23 (26.4) |
| Renal status, ** n (%) | ||||
| Normal | 311 (48.1) | 312 (48.5) | 56 (61.5) | 46 (52.9) |
| Mild impairment | 201 (31.1) | 192 (29.9) | 25 (27.5) | 26 (29.9) |
| Moderate impairment | 125 (19.3) | 132 (20.5) | 8 (8.8) | 15 (17.2) |
| Severe impairment | 7 (1.1) | 6 (0.9) | 2 (2.2) | 0 |
| Missing | 2 (0.3) | 1 (0.2) | 0 | 0 |
| Medical history, †† n (%) | ||||
| Smoking history | 284 (44.0) | 242 (37.6) | 35 (38.5) | 25 (28.7) |
| Hypertension | 248 (38.4) | 253 (39.3) | 35 (38.5) | 29 (33.3) |
| Asthma/COPD | 119 (18.4) | 113 (17.6) | 10 (11.0) | 10 (11.5) |
| Diabetes mellitus | 80 (12.4) | 88 (13.7) | 7 (7.7) | 12 (13.8) |
| Baseline pathogen, ‡‡ n (%) | ||||
| Mycoplasma pneumoniae | 39 (6.0) | 34 (5.3) | 39 (42.9) | 34 (39.1) |
| Legionella pneumophila | 34 (5.3) | 31 (4.8) | 34 (37.4) | 31 (35.6) |
| Chlamydia pneumoniae | 27 (4.2) | 31 (4.8) | 27 (29.7) | 31 (35.6) |
| Streptococcus pneumoniae | 216 (33.4) | 223 (34.7) | 24 (26.4) | 29 (33.3) |
| Haemophilus influenzae | 107 (16.6) | 105 (16.3) | 8 (8.8) | 13 (14.9) |
| Moraxella catarrhalis | 46 (7.1) | 22 (3.4) | 7 (7.7) | 1 (1.1) |
| Staphylococcus aureus | 23 (3.6) | 10 (1.6) | 5 (5.5) | 1 (1.1) |
ATS, American Thoracic Society; BUN, blood urea nitrogen; CABP, community-acquired bacterial pneumonia; COPD, chronic obstructive pulmonary disease; CrCl, creatinine clearance; HLT, high-level term; ITT, intent to treat; MedDRA, Medical Dictionary for Regulatory Activities; microITT, microbiological ITT; NEC, not elsewhere classified; PORT, Pneumonia Outcomes Research Team; SIRS, systemic inflammatory response syndrome; WBC, white blood cell (count). * Defined as M. pneumoniae, L. pneumophila, and C. pneumoniae. † PORT risk class calculated programmatically using site data reported in the electronic case report form was not always consistent with the site-reported PORT risk class used for enrollment/stratification. ‡ Defined as confusion of new onset, BUN > 19 mg/dL, respiratory rate ≥ 30 breaths/min, systolic blood pressure < 90 mm Hg or diastolic blood pressure ≤ 60 mm Hg, and age ≥ 65 years. § Defined as baseline presence of ≥3 of the following nine criteria: respiratory rate ≥ 30 breaths/min, O2 saturation < 90% or PaO2 < 60 mm Hg, BUN ≥ 20 mg/dL, WBC < 4000 cells/mm3, confusion, multilobar infiltrates, platelets < 100,000 cells/mm3, temperature < 36 °C, or systolic blood pressure < 90 mm Hg [17]. || Defined as baseline presence of ≥3 of the following six criteria: respiratory rate ≥ 30 breaths/min, SpO2/FiO2 < 274 where SpO2/FiO2 = 64 + 0.84 (PaO2/FiO2), BUN ≥ 20 mg/dL, confusion, age ≥ 65 years, or multilobar infiltrates [43]. Defined as baseline presence of ≥2 of the following four criteria: temperature < 36 °C or >38 °C; heart rate >90 bpm; respiratory rate > 20 breaths/min; and WBC < 4000 cells/mm3, WBC > 12,000 cells/mm3, or immature polymorphonuclear neutrophils > 10%. # Patients received a single dose of short-acting systemic antibacterial medication ≤ 72 h before randomization; randomization was stratified and capped such that ≤25% of the total ITT population met these criteria. ** Defined as normal (CrCl ≥ 90 mL/min), mild (CrCl 60– < 90 mL/min), moderate (CrCl 30– < 60 mL/min), and severe (CrCl < 30 mL/min). †† Medical history terms were defined as follows: hypertension = MedDRA HLT “vascular hypertensive disorders NEC”; asthma/COPD = MedDRA HLT “bronchospasm and obstruction”; diabetes mellitus = MedDRA HLT “diabetes mellitus (incl subtypes)”. ‡‡ Among the subpopulation of patients with atypical pathogens (M. pneumoniae, L. pneumophila, C. pneumoniae), all patients had ≥1 atypical pathogen at baseline, with the corresponding infections being either mono- or polymicrobial. Within those polymicrobial infections that occurred in patients with atypical pathogens, additional baseline pathogens of S. pneumoniae, H. influenzae, M. catarrhalis, and S. aureus were identified.