Ignite Creation Date:
2024-05-05 @ 9:32 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00908713
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2009-05-26
Brief Title:
Corticoids in Severe Community-Acquired Pneumonia CAP
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Corticoids in Severe Community-acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the efficacy of glucocorticoids as an adjuvant therapy in patients with severe community-acquired pneumonia CAP Fine V The hypothesis of the study is that glucocorticoids can modulate the excessive inflammatory response in patients with severe CAP without any significant side effects showing a benefit in the percentage of non-response to the empiric antimicrobial treatment
Detailed Description:
Community acquired pneumonia CAP is associated with a local and systemic inflammatory response conducted by different pro and counter inflammatory cytokines The evolution of the infection is mainly dependent on the intensity of the inflammatory response The AIM of the project is to determine the clinical usefulness of methylprednisolone treatment 05 mg Kg weight every 12h for 5 days in patients with severe CAP and an excessive inflammatory response patients identified based on a cut-off point of the reactive C protein RCP of 15 mgdl A randomized double blind placebo controlled study with two arms will be performed The study group patients with excessive inflammatory response will receive methylprednisolone antibiotics Control group will receive placebo antibiotics Patients older than 18 years with Fine V pneumonia will be recruited Clinical data and prognostic factors APACHE II and SOFA scores etiology mortality at ICU and at 28 days will be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None