Effects of low-dose corticosteroids on survival of severe Community-Acquired Pneumonia - CAPE COD

CHRU de TOURS0 个研究点目标入组 1,200 人开始时间: 2015年7月29日最近更新: 2021年8月2日

试验速览

暂无简介。

•Age = 18 years
•Admission to an ICU or intermediate care unit participating to the trial
•Diagnosis of 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 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 lower than 200
•Patient already treated by antibiotics (at least one dose)
•Patients affiliated to social security scheme (Sécurité sociale”)
•Informed consent signed by the patient, its relatives or emergency procedure
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 600
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 600

•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 five 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
•Decision of withholding mechanical ventilation or endotracheal intubation
•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
•Pregnant or breastfeeding woman
•Patient on judicial protection

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