Extended Steroid in CAP(e) (ESCAPe)

Inclusion Criteria:

• Patient's origin. Patients are classified as having CAP if they are admitted directly from outside the hospital, including private residence, nursing home, rehabilitation center, other long-term care facility (health care-associated pneumonia-HCAP).
• Clinical diagnosis of CAP.

• Have radiographically confirmed pneumonia (new or progressive pulmonary infiltrate(s) on chest radiograph or chest computed tomography scan consistent with bacterial pneumonia) AND Have acute illness ( 7 days' duration) with at least three of the following clinical signs or symptoms consistent with a lower respiratory tract infection:

  • New or increased cough
  • Purulent sputum or change in sputum character
  • Auscultatory findings consistent with pneumonia (e.g., rales, egophony, findings of consolidation)
  • Dyspnea, tachypnea, or hypoxemia (O2 saturation <90% on room air or PaO2 <60 mmHg)
  • Fever greater than 38 C oral (>38.5 C rectally or tympanically) or hypothermia (<35 C)
  • White blood cell count greater than 10,000 cells/mm3 or less than 4,500 cells/mm3
  • Greater than 15% immature neutrophils (bands) irrespective of WBC count

• Diagnosis of severe CAP. Pneumonia of sufficient severity to require admission to the ICU (including intermediate care unit) by meeting at least three of five CURB-65 criteria or need for mechanical ventilation:

  • CURB-65 criteria1.Respiratory rate >30 breaths/min
  • Confusion/disorientation
  • Uremia (BUN >20 mg/dL)
  • Hypotension: SBP <90 or DBP <60
  • Age >65 years
• OR Need for invasive or noninvasive mechanical ventilation -- Legend: BUN = blood urea nitrogen; SBP = systolic blood pressure (mmHg); DBP = diastolic blood pressure (mmHg).

Exclusion Criteria:

• Patient's age 17 years or younger.
• Vasopressor-dependent shock requiring moderate-to-high dose vasopressor (i.e., norepinephrine 0.3 mcg/Kg/min) treatment for greater than 2 hours in patient that is adequately fluid-resuscitated (at least 4 liters of crystalloids) WITH central venous pressure (CVP) equal to or greater than 8 mm Hg for nonventilated patients and equal to or greater than 12 mm Hg for ventilated patients. (See explanation below)*
• Major gastrointestinal bleeding requiring transfusion of 5 units or more of packed red blood cells within 3 months of current hospitalization.
• Any condition requiring 20 mg of prednisone equivalent/day for greater than 14 days, over the last 3 months.
• COPD with acute exacerbation requiring glucocorticoid treatment at hospital admission. Patients with short-term glucocorticoid use (e.g., methylprednisolone up to 60 mg/day for 5 days) will not be excluded.
• Patients enrolled in another experimental (interventional) protocol.
• Pregnancy, confirmed by urine or serum test.
• Presence of postobstructive pneumonia or cystic fibrosis.
• Clinical history consistent with aspiration of gastric content (i.e., loss of consciousness or seizure).
• Active tuberculosis or fungal infection.
• Moribund patient (i.e., not expected to live more than 24 h) or with recent (within 7 days) cardiopulmonary arrest, or with (known or suspected) irreversible cessation of all brain function, or comfort measure status.
• Presence of preexisting medical condition that is irreversible and expected to be fatal within 3 months.
• Patients with severe immunosuppression (i.e., HIV with CD4 <200), neutropenia (less than 1000 neutrophils) not related to pneumonia, acute burn injury, or receiving immunosuppressive or cytotoxic therapy for any reason.
• Chronic severe cognitive impairment caused by dementia or central nervous system pathologies (tumor, cerebro-vascular accident, infections, or head injuries) as defined by the site investigator by obtaining medical history and reviewing medical record.