Table 1.
Baseline characteristics
| Characteristic | Methylprednisolone (n = 297) | Placebo (n = 287) |
|---|---|---|
| Age—years | 69 ± 10.8 | 68.6 ± 11.1 |
| Male sex—no./total no. (%) | 289/297 (97) | 273/286 (95) |
| Ethnicity—no./total no. (%) | ||
| Not Spanish, Hispanic or Latino | 255/286 (89) | 251/280 (90) |
| Mexican, Mexican American, or Chicano | 16/286 (6) | 12/280 (4) |
| Puerto Rican | 5/286 (2) | 8/280 (3) |
| Cuban | 0 (0) | 1/280 (0) |
| Other Spanish, Hispanic or Latino | 10/286 (3) | 8/280 (3) |
| Race—no./total no. (%) | ||
| White | 245/287 (85) | 227/281 (81) |
| Black/African American | 36/287 (13) | 48/281 (17) |
| Other | 15/287 (5) | 10/281 (4) |
| BMI ≥ 30—no./total no. (%) | 62/297 (21) | 70/285 (25) |
| Smoking status—no./total no. (%) | ||
| Current smoker | 98/294 (33) | 89/284 (31) |
| Prior smoker (not current smoker) | 155/294 (53) | 139/284 (49) |
| Lifetime non-smoker | 41/294 (14) | 56/284 (20) |
| Any major comorbidity—no./total no. (%) | 290/297 (98) | 275/285 (96) |
| No. of major comorbidities | 4 ± 1.8 | 3.9 ± 1.9 |
| Charlson Comorbidity Index | 5.77 ± 2.39 | 5.65 ± 2.24 |
| ACE27 Overall Comorbidity Score—no./total no. (%) | ||
| 0 | 6/297 (2) | 8/285 (3) |
| 1 | 38/297 (13) | 33/285 (12) |
| 2 | 51/297 (17) | 59/285 (21) |
| 3 | 202/297 (68) | 185/285 (65) |
| ACE27 Total Score | 2.51 ± 0.79 | 2.48 ± 0.81 |
| Karnofsky Performance Score | 72.4 ± 22 | 72.9 ± 22.4 |
| HCAP—no./total no. (%) | 112/297 (38) | 89/287 (31) |
| Resided in nursing home or long-term care facility immediately prior to hospital admission | 40/297 (13) | 48/287 (17) |
| Hospitalized in acute care hospital for 2 or more days within past 90 days | 81/297 (27) | 58/287 (20) |
| Received intravenous therapy (antibiotic or chemotherapy) within past 30 days | 42/297 (14) | 31/287 (11) |
| Received home wound care within past 30 days | 18/297 (6) | 13/287 (5) |
| Received hemodialysis within past 30 days | 10/297 (3) | 8/287 (3) |
| Admission from the ward—no. (%) | 66/297 (22) | 57/287 (20) |
| Time from hospital admission to randomization—days, median (IQ R) | 1.7 (1–2.2) | 1.4 (0.9–2) |
| PSI | 125.6 ± 37.2 | 122.3 ± 34.4 |
| PSI class—no. (%) | ||
| I | 3/297 (1) | 4/285 (1) |
| II | 13/297 (4) | 13/285 (5) |
| III | 41/297 (14) | 29/285 (10) |
| IV | 121/297 (41) | 126/285 (44) |
| V | 119/297 (40) | 113/285 (40) |
| PIRO | 2.14 ± 1.12 | 2.15 ± 1.1 |
| CURB-65 | 2.69 ± 1.03 | 2.59 ± 1.03 |
| Chest Radiograph Score | 2.09 ± 1.02 | 1.94 ± 1.08 |
| Bilateral—no./total no. (%) | 189/288(66) | 163/276 (59) |
| Multilobar—no./total no. (%) | 216/297 (73) | 188/285 (66) |
| PaO2/FiO2 (if PaO2 is available)a | 181 ± 85 | 188 ± 90 |
| SpO2/FiO2 (if PaO2 is not available)b | 283 ± 101 | 286 ± 98 |
| ALI-ARDS at randomization—no./total no. (%) | 26/297 (9) | 39/285 (14) |
| Bacteremia—no./total no. (%) | 49/282 (17) | 32/275 (12) |
| White Blood Cell Count (× 106 cells/mL) | 15.25 ± 12.44 | 14.55 ± 7.23 |
| APACHE III Score | 54.3 ± 29.4 | 53.4 ± 28.7 |
| SAPS III Score | 59.4 ± 10.7 | 58.5 ± 9.9 |
| SOFA Score | 6.68 ± 3 | 6.29 ± 2.85 |
| Lactate level (mmol/L)c | 1.84 ± 1.25 | 1.82 ± 1.81 |
| MV at study entry—no./total no. (%) | 97/297 (33) | 96/287 (33) |
| Vasopressor dependent Shock at or prior to study entry—no./total no. (%) | 44/296 (15) | 32/285 (11) |
| Use of anti-inflammatory medications at baseline—no./total no. (%)d | 241/297 (81) | 221/286 (77) |
| Use of macrolide antibiotics at baseline—no./total no. (%) | 64/297 (22) | 52/286 (18) |
| Antibiotic treatment in the participants who were not admitted from other hospital—no./total no. (%)e | ||
| Did not receive initial antibiotics | 34/278 (12) | 34/271 (13) |
| Received initial antibiotics within 6 h of hospital admission | 232/278 (83) | 222/271 (82) |
| Received initial antibiotics beyond 6 h of hospital admission | 11/278 (4) | 9/271 (3) |
| Unknown | 1/278 (0) | 6/271 (2) |
| Adequate initial antibiotic treatment based on guidelinesf—no./total no. (%) | 286/293 (98) | 265/278 (95) |
| Tested for Influenza—no./total no. (%) | 182/294 (62) | 173/277 (62) |
| Tested positive for influenza in participants who were tested for influenza—no./total no. (%) | 14/144 (10) | 11/131 (8) |
| Tested positive for both influenza and bacteria—no./total no. (%) | 7/297 (2) | 6/287 (2) |
BMI body mass index; ACE adult comorbidity evaluation; PSI pneumonia severity illness; HCAP health-care-associated pneumonia; PIRO predisposition, insult, response, and organ dysfunction; CURB-65 (confusion, uremia, respiratory rate, BP, age ≥ 65 years); ALI-ARDS acute lung injury- acute respiratory distress syndrome, APACHE Acute Physiology and Chronic Health Evaluation; SAPS Simplified Acute Physiology Score; SOFA Sequential Organ Failure Assessment; MV mechanical ventilation
a379 participants had a PaO2/FiO2 measurement (201 in the methylprednisolone group, 178 in the placebo group)
b167 participants had an SpO2/FiO2 measurement (79 in the methylprednisolone group, 88 in the placebo group)
c514 participants had a Lactate Level measurement (261 in the methylprednisolone group, 253 in the placebo group)
d240 (41%) participants used aspirin at baseline (122 in the methylprednisolone group, 118 in the placebo group); and 58 (10%) participants used systemic corticosteroids (31 in methylprednisolone, 27 in placebo)
eExcludes one participant with time to initial antibiotic treatment from hospital admission longer than 700 h. This value was mostly likely due to a data entry error
fExcludes participants who did not receive antibiotics within 6 h of hospital admission