Community-Acquired Pneumonia : Evaluation of Corticosteroids (CAPE_COD)
Community Acquired Pneumonia
About this trial
This is an interventional treatment trial for Community Acquired Pneumonia focused on measuring Community-Acquired Pneumonia (CAP), Hydrocortisone, Corticosteroids, COronaVIrus Disease
Eligibility Criteria
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
Sites / Locations
- Service de Réanimation - Unité de Soins Continus, CH d'Angoulême
- Service de Réanimation Polyvalente, CH d'Argenteuil
- Service de Réanimation, CHR Metz-Thionville
- Service de Réanimation
- Service de Réanimation
- Service de Réanimation
- Service de Réanimation HIA Clermont-Tonnerre
- Service de Réanimation Médicale, CHU de Brest
- Service de Réanimation, CHU Côte de Nacre
- Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres
- Service de Réanimation Médicale Polyvalente, Hôpital G Montpied
- Service de Réanimation, Hôpital Louis Mourier
- Service de Réanimation Médicale, CHU de Dijon
- Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP
- Service de Réanimation Médicale, CHU de Grenoble
- Service de Réanimation Polyvalente, CHD La Roche sur Yon
- Service de Réanimation, CH Le Mans
- Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille
- Service de Réanimation Polyvalente, CHU de Limoges
- Service de Réanimation Médicale, Hôpital Nord
- Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban
- Service de Réanimation Médicale, CHU de Nancy
- Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes
- Service de Réanimation Médicale, CHR d'Orléans
- Service de Réanimation Médicale, Hôpital Cochin, APHP
- Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP
- Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers
- Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes
- Service de Réanimation Polyvalente, CH de Saint Malo
- Service de Réanimation
- Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg
- Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Hydrocortisone
Placebo
Patients in the treatment group will receive intra-venous hydrocortisone (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP)
Patients of the control group will receive an intravenous placebo by intravenous route (in addition to the standard treatment of severe Community-Acquired Pneumonia (CAP)