Table 1. Demographic and Baseline Characteristics of the Intent-to-Treat Population.
| Characteristic | Lefamulin (n = 370) | Moxifloxacin (n = 368) |
|---|---|---|
| Demographics | ||
| Age, mean (SD), y | 57.4 (16.4) | 57.7 (16.2) |
| Age group, No. (%) | ||
| <65 y | 234 (63.2) | 227 (61.7) |
| 65-74 y | 78 (21.1) | 79 (21.5) |
| ≥75 y | 58 (15.7) | 62 (16.8) |
| Sex, No. (%) | ||
| Male | 207 (55.9) | 180 (48.9) |
| Female | 163 (44.1) | 188 (51.1) |
| Body mass index, mean (SD)a | 26.5 (5.7) | 26.5 (5.8) |
| Race, No. (%)b | ||
| White | 274 (74.1) | 270 (73.4) |
| Asian | 48 (13.0) | 52 (14.1) |
| American Indian or Alaskan native | 24 (6.5) | 16 (4.3) |
| Black or African American | 19 (5.1) | 22 (6.0) |
| Other | 5 (1.4) | 8 (2.2) |
| Hispanic or Latino ethnicity, No. (%)b | 45 (12.2) | 38 (10.3) |
| Vital Signs, Mean (SD) | ||
| Pulse rate, beats/min | 95.3 (18.4) | 94.4 (18.0) |
| Blood pressure, mm Hg | ||
| Systolic | 118.6 (21.2) | 115.9 (20.6) |
| Diastolic | 74.3 (12.0) | 72.8 (11.2) |
| Temperature, °C | 38.7 (1.0) | 38.6 (1.1) |
| Respiratory rate, breaths/min | 24.8 (4.3) | 24.8 (4.4) |
| Disease Severity, No. (%) | ||
| PORT risk classc | ||
| I (least severe) | 1 (0.3) | 2 (0.5) |
| II | 183 (49.5) | 189 (51.4) |
| III | 145 (39.2) | 133 (36.1) |
| IV | 40 (10.8) | 42 (11.4) |
| V (most severe) | 1 (0.3) | 2 (0.5) |
| Met American Thoracic Society severity criteria | ||
| Minord | 31 (8.4) | 37 (10.1) |
| Modifiede | 20 (5.4) | 22 (6.0) |
| Met SIRS criteriaf | 353 (95.4) | 342 (92.9) |
| Bacteremia | 6 (1.6) | 9 (2.4) |
| Multilobar pneumonia | 88 (23.8) | 101 (27.4) |
| Received systemic antibacterial medication within 72 h prior to randomization | 78 (21.1) | 74 (20.1) |
| Comorbidities, No. (%) | ||
| Vascular disorders | 138 (37.3) | 145 (39.4) |
| Kidney impairment | ||
| Any (creatinine clearance <90 mL/min) | 180 (48.6) | 190 (51.6) |
| Moderate to severe (creatinine clearance <60 mL/min) | 68 (18.4) | 73 (19.8) |
| Diabetes | 48 (13.0) | 51 (13.9) |
| Cardiac disorders | 46 (12.4) | 53 (14.4) |
| Chronic obstructive pulmonary disease | 38 (10.3) | 33 (9.0) |
| Asthma | 23 (6.2) | 29 (7.9) |
| Current or previous smoker | 163 (44.1) | 135 (36.7) |
| Location, No. (%) | ||
| Eastern Europe | 236 (63.8) | 218 (59.2) |
| Latin America and Mexicog | 38 (10.3) | 34 (9.2) |
| Western Europe | 17 (4.6) | 19 (5.2) |
| United States | 11 (3.0) | 12 (3.3) |
| Asia and Africa | 68 (18.4) | 85 (23.1) |
Abbreviations: PORT, Pneumonia Outcomes Research Team; SIRS, systemic inflammatory response syndrome.
Calculated as weight in kilograms divided by height in meters squared.
Data on race and ethnicity were entered into the case report by the study site using fixed categories. The method by which patients were asked their identified race/ethnicity and whether the categories were used in a closed-ended or open-ended fashion is unknown and may have varied by investigator, study coordinator, and study site.
A clinical prediction rule used to calculate risk of morbidity and mortality among patients presenting with community-acquired pneumonia taking into consideration age, history of comorbid conditions, physical examination findings, and laboratory or radiographic results.24 The specific methods used to calculate and determine PORT risk class in this trial were described in supplement methods 1 in the article by File et al.15
Defined as presence of 3 or more of the following 9 criteria at baseline: respiratory rate of 30/min or greater, oxygen saturation less than 90% or Pao2 less than 60 mm Hg, blood urea nitrogen level of 20 mg/dL or greater, white blood cell count less than 4000/mm3, confusion, multilobar infiltrates, platelet level less than 100 000 cells/mm3, temperature lower than 36°C, or systolic blood pressure less than 90 mm Hg.
Defined as presence of 3 or more of the following 6 criteria at baseline: respiratory rate of 30/min or greater, oxygen saturation as measured by pulse oximetry (Spo2) divided by fraction of inspired oxygen (Fio2) of less than 274 where Spo2 divided by Fio2 equals 64 plus 0.84 (Pao2/Fio2), blood urea nitrogen level of 20 mg/dL or greater, confusion, age of 65 years or older, or multilobar infiltrates.
Defined as 2 or more of the following 4 symptoms at baseline: temperature less than 36°C or greater than 38°C; heart rate greater than 90/min; respiratory rate greater than 20/min; white blood cell count less than 4000 cells/mm3, white blood cell count greater than 12 000 cells/mm3, or immature polymorphonuclear neutrophils greater than 10%. The proportion of patients who met individual SIRS criteria appear in eTable 1 in Supplement 2.
Latin America includes patients from the countries of Argentina, Chile, and Peru.