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Table 1 Demographic and baseline characteristics (pooled ITT population)

From: Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities

Parameter

Lefamulin

(n = 646)

Moxifloxacin

(n = 643)

Overall

(N = 1289)

Age, y, mean (SD)

58.9 (16.5)

58.5 (15.7)

58.7 (16.1)

Age group, years, n (%)

   

 18‒64

378 (58.5)

394 (61.3)

772 (59.9)

 65‒74

152 (23.5)

145 (22.6)

297 (23.0)

 75–84

90 (13.9)

87 (13.5)

177 (13.7)

 ≥ 85

26 (4.0)

17 (2.6)

43 (3.3)

Male, n (%)

377 (58.4)

340 (52.9)

717 (55.6)

White, n (%)

513 (79.4)

509 (79.2)

1022 (79.3)

BMI, kg/m2, mean (SD)

26.5 (5.8)

26.4 (6.0)

26.5 (5.9)

PORT risk class,* n (%)

   

 I/II

184 (28.5)

192 (29.9)

376 (29.2)

 III

341 (52.8)

334 (51.9)

675 (52.4)

 IV/V

121 (18.7)

117 (18.2)

238 (18.5)

CURB-65 score,† n (%)

   

 0‒2

610 (94.4)

604 (93.9)

1214 (94.2)

 3‒5

36 (5.6)

39 (6.1)

75 (5.8)

Minor ATS severity criteria,‡ n (%)

85 (13.2)

85 (13.2)

170 (13.2)

Modified ATS severity criteria,§ n (%)

53 (8.2)

57 (8.9)

110 (8.5)

Prior antibiotic use,|| n (%)

147 (22.8)

145 (22.6)

292 (22.7)

Baseline renal status,¶ n (%)

   

 Normal function

311 (48.1)

312 (48.5)

623 (48.3)

 Mild impairment

201 (31.1)

192 (29.9)

393 (30.5)

 Moderate impairment

125 (19.3)

132 (20.5)

257 (19.9)

 Severe impairment

7 (1.1)

6 (0.9)

13 (1.0)

 Missing

2 (0.3)

1 (0.2)

3 (0.2)

Medical history,# n (%)

   

 Smoking history

284 (44.0)

242 (37.6)

526 (40.8)

 Hypertension

248 (38.4)

253 (39.3)

501 (38.9)

 Baseline liver enzyme elevation

119 (18.4)

144 (22.4)

263 (20.4)

 Asthma/COPD

119 (18.4)

113 (17.6)

232 (18.0)

 Diabetes mellitus

80 (12.4)

88 (13.7)

168 (13.0)

 Congestive heart failure

57 (8.8)

75 (11.7)

132 (10.2)

 Arrhythmia

43 (6.7)

30 (4.7)

73 (5.7)

 SIRS,** n (%)

621 (96.1)

609 (94.7)

1230 (95.4)

 Bacteremia, n (%)

13 (2.0)

12 (1.9)

25 (1.9)

  1. ATS American Thoracic Society, BMI body mass index, BUN blood urea nitrogen, COPD chronic obstructive pulmonary disease, CrCl creatinine clearance, ITT intent to treat, PORT Pneumonia Outcomes Research Team, SIRS systemic inflammatory response syndrome, WBC white blood cell (count)
  2. *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; consequently, 3 patients with PORT risk class I (lefamulin, n = 1; moxifloxacin, n = 2) were enrolled
  3. †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
  4. ‡Defined as baseline presence of ≥ 3 of the following 9 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 [40]
  5. §Defined as baseline presence of ≥ 3 of the following 6 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 [41]
  6. ||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
  7. ¶Defined as normal (CrCl ≥ 90 mL/min), mild (CrCl 60 to < 90 mL/min), moderate (CrCl 30 to < 60 mL/min), and severe (CrCl < 30 mL/min)
  8. #See Additional file 2: Supplemental Table 1 for definitions of medical history terms
  9. **Defined as baseline presence of ≥ 2 of the following 4 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%
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BMC Pulmonary Medicine

ISSN: 1471-2466

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