Community-Acquired Pneumonia : Evaluation of COrticosteroiDs (CAPE COD)

Phase 1

• Conditions: Severe community-acquired pneumonia; MedDRA version: 18.0Level: LLTClassification code 10010120Term: Community acquired pneumoniaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001239-19-FR
• Lead Sponsor: CHRU de TOURS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-29
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• 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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified