Community-Acquired Pneumonia : Evaluation of Corticosteroids (CAPE_COD)

This is an interventional treatment trial for Community Acquired Pneumonia focused on measuring Community-Acquired Pneumonia (CAP), Hydrocortisone, Corticosteroids, COronaVIrus Disease Read More

Inclusion Criteria:

• Age ≥ 18 years
• Patients affiliated to social security scheme
• Admission to an Intensive Care Unit (ICU) or intermediate care unit participating to the trial
• Diagnosis of Community- Acquired Pneumonia (CAP) suggested by at least two of the following: cough, purulent sputum, chest pain and dyspnea
• Focal shadowing/infiltrate on chest X-ray or CT-scan
• Diagnosis of Community- Acquired Pneumonia (CAP) during the 48 hours post-hospital admission
• Study drug infusion initiated no longer than 24 hours post first severity criterion

• Severity defined by at least one of the following:

  • Pneumonia Severity Index (PSI) > 130 (Fine class V)
  • Patient placed on mechanical ventilation (invasive or not) for acute respiratory failure, with a PEEP level of 5 cm of water or more
  • Patient treated by high-flow oxygen therapy with a FiO2 of 50% or more and a P/F ratio less than 300
  • Patient treated by oxygen therapy with a partial rebreathing-mask with a reservoir bag, provided that the PaO2 is less than (cf. table):

Oxygen flow (L/min) 6 7 8 9 10 or more PaO2 (mmHg) less than 180 210 240 270 300

• Patient already treated by antibiotics (at least one dose since admission to hospital)
• Informed consent signed by the patient, its relatives or emergency procedure

On the sub-group of patients included with COVID19 :

• Diagnosis of COVID19 either as certain (PCR) or probable (evocative clinical and radiological features AND epidemic context AND absence of other microbiological documentation).
• Study drug infusion initiated no longer than 24 hours post first severity criterion ; in case of transfer from another hospital, this period will be prolonged to 48 hours
• Patient receiving the best available treatment as define by up-to-date scientific knowledge

Exclusion Criteria:

• Patient treated by vasopressors for septic shock at the time of inclusion
• Clinical history suggesting of aspiration of gastric content
• Patient treated by invasive mechanical ventilation within 14 days before current hospital admission
• Patient treated by antibiotics for a respiratory infection for more than seven days at the admission to the hospital (except if a pathogen resistant to this antibiotics is isolated)
• History of cystic fibrosis
• Post-obstructive pneumonia
• Patients in which rapid PCR-test is positive for flu
• Active tuberculosis or fungal infection
• Active viral hepatitis or active infection with herpes viruses
• Myelosuppression
• Decision of withholding mechanical ventilation or endotracheal intubation
• Hypersensitivity to corticosteroids
• Patient needing anti-inflammatory corticosteroids or substitutive hydrocortisone for any reason
• Patients under treatment by more than 15 mg/d of prednisone (or equivalent) for more than 30 days
• Patient already enrolled in another drug trial with mortality as an end-point. If the patient is already participating in another therapeutic trial with a different endpoint, the investigator must verify that inclusion in CAPE COD can not prejudice it.
• Pregnant or breastfeeding woman
• Patient on judicial protection