Phase
Condition
Pneumonia
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years
- Patients affiliated to social security scheme
- Admission to an Intensive Care Unit (ICU) or intermediate care unit participating tothe trial
- Diagnosis of Community- Acquired Pneumonia (CAP) suggested by at least two of thefollowing: 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-hospitaladmission
- 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 respiratoryfailure, 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/Fratio less than 300
- Patient treated by oxygen therapy with a partial rebreathing-mask with areservoir 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 andradiological features AND epidemic context AND absence of other microbiologicaldocumentation).
- 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 scientificknowledge
Exclusion
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 currenthospital admission
- Patient treated by antibiotics for a respiratory infection for more than seven days atthe admission to the hospital (except if a pathogen resistant to this antibiotics isisolated)
- 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 forany reason
- Patients under treatment by more than 15 mg/d of prednisone (or equivalent) for morethan 30 days
- Patient already enrolled in another drug trial with mortality as an end-point. If thepatient is already participating in another therapeutic trial with a differentendpoint, the investigator must verify that inclusion in CAPE COD can not prejudiceit.
- Pregnant or breastfeeding woman
- Patient on judicial protection
Study Design
Study Description
Connect with a study center
Service de Réanimation - Unité de Soins Continus, CH d'Angoulême
'Angoulême, 16959
FranceSite Not Available
Service de Réanimation Polyvalente, CH d'Argenteuil
Argenteuil, 95107
FranceSite Not Available
Service de Réanimation, CHR Metz-Thionville
Ars-Laquenexy, 57530
FranceSite Not Available
Service de Réanimation
Aulnay-sous-Bois, 93602
FranceSite Not Available
Service de Réanimation
Belfort, 90015
FranceSite Not Available
Service de Réanimation
Bourg-en-Bresse,
FranceSite Not Available
Service de Réanimation HIA Clermont-Tonnerre
Brest, 29240
FranceSite Not Available
Service de Réanimation Médicale, CHU de Brest
Brest, 29609
FranceSite Not Available
Service de Réanimation, CHU Côte de Nacre
Caen, 14033
FranceSite Not Available
Service de Réanimation Médicale, Hôpital Louis Pasteur, Chartres
Chartres, 28000
FranceSite Not Available
Service de Réanimation Médicale Polyvalente, Hôpital G Montpied
Clermont Ferrand, 63003
FranceSite Not Available
Service de Réanimation, Hôpital Louis Mourier
Colombes, 92700
FranceSite Not Available
Service de Réanimation Médicale, CHU de Dijon
Dijon, 21079
FranceSite Not Available
Service de Réanimation Médico-Chirurgicale, Hôpital Raymond Poincarré, APHP
Garches, 92380
FranceSite Not Available
Service de Réanimation Médicale, CHU de Grenoble
Grenoble, 38043
FranceSite Not Available
Service de Réanimation Polyvalente, CHD La Roche sur Yon
La Roche sur Yon, 85925
FranceSite Not Available
Service de Réanimation, CH Le Mans
Le Mans, 72037
FranceSite Not Available
Service de Réanimation Polyvalente, Hôpital Salengro, CHU de Lille
Lille, 59037
FranceSite Not Available
Service de Réanimation Polyvalente, CHU de Limoges
Limoges, 87042
FranceSite Not Available
Service de Réanimation Médicale, Hôpital Nord
Marseille, 13015
FranceSite Not Available
Service de Réanimation Polyvalente - Surveillance Continue, CH de Montauban
Montauban, 82013
FranceSite Not Available
Service de Réanimation Médicale, CHU de Nancy
Nancy, 54511
FranceSite Not Available
Service de Réanimation Polyvalente, Hôpital Hôtel Dieu, CHU de Nantes
Nantes, 44093
FranceSite Not Available
Service de Réanimation Médicale, CHR d'Orléans
Orléans, 45067
FranceSite Not Available
Service de Réanimation Médicale, Hôpital Cochin, APHP
Paris, 75014
FranceSite Not Available
Service de Réanimation et USC médico-chirurgicale, Hôpital Tenon, APHP
Paris, 75020
FranceSite Not Available
Service de Réanimation Médicale et Médecine Interne, CHU de Poitiers
Poitiers, 86021
FranceSite Not Available
Service des Maladies Infectieuses et Réanimation Médicale, CHU de Rennes
Rennes, 35033
FranceSite Not Available
Service de Réanimation Polyvalente, CH de Saint Malo
Saint Malo, 35403
FranceSite Not Available
Service de Réanimation
Saint-Brieuc, 22000
FranceSite Not Available
Service de Réanimation Médicale, Hôpital de Hautepierre, CHU de Strasbourg
Strasbourg, 67098
FranceSite Not Available
Service de Réanimation Médicale, Nouvel Hôpital Civil, CHU de Strasbourg
Strasbourg, 67091
FranceSite Not Available
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