Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01143155
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2010-06-10
Brief Title:
Failure and Cardiovascular Events in Community-acquired Pneumonia
Sponsor:
University of Milan
Organization:
University of Milan
Study Overview
Official Title:
Clinical Failure and Cardiovascular Events in Hospitalized Patients With Community-Acquired Pneumonia The Failcap Study
Status:
COMPLETED
Status Verified Date:
2013-12
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:
FAILCAP
Brief Summary:
Although failure and mortality are the most relevant outcomes in patients with Community-acquired Pneumonia CAP there is little discussion in the literature on their incidence and etiology A pathophysiological approach has been recently developed and used to evaluate clinical failure in CAP patients Clinical failure has been analyzed as related versus unrelated to CAP considering the role that the pulmonary infection and the inflammatory response played in the development of this outcome Cardiac events were identified as triggers of clinical failures in a significant percentage of CAP patients The development of cardiovascular events have been also identified in CAP patients both on admission to the hospital and during hospitalization However data on this topic belong to studies evaluating only selected populations of veteran patients with CAP Understanding clinical failure as well as cardiovascular events in hospitalized patients with CAP would be useful in order to prevent complications during the hospitalization to develop new treatment modalities and thus to improve outcomes
The objectives of this international multicenter observational prospective cohort study will be 1 To define incidence timing etiology and risk factors of clinical failure related vs unrelated to CAP in hospitalized patients with CAP 2 To define incidence timing and risk factors for cardiovascular events either on hospital admission or during hospitalization in hospitalized patients with CAPConsecutive adult patients hospitalized for CAP in acute care hospitals in Europe and US will be enrolled Daily clinical evaluations Demographics history clinical radiological and antibiotic therapy data will be recorded as well as serum urinary and respiratory samples will be collected both on admission and during hospitalization from consenting individuals Patients will be classified as having a CAP-related versus CAP-unrelated failure according to a pathophysiological classification Patients will be also classified as having or not a cardiovascular event either on admission or during hospitalizationThe following outcomes will be measured
1 Incidence timing etiology and risk factors of clinical failure related vs unrelated to CAP 2 Incidence timing and risk factors of cardiovascular events 3time to clinical stability length of hospital stay mortality at hospital discharge and mortality at 30 and 180 days
The objectives of this international multicenter observational prospective cohort study will be 1 To define incidence timing etiology and risk factors of clinical failure related vs unrelated to CAP in hospitalized patients with CAP 2 To define incidence timing and risk factors for cardiovascular events either on hospital admission or during hospitalization in hospitalized patients with CAPConsecutive adult patients hospitalized for CAP in acute care hospitals in Europe and US will be enrolled Daily clinical evaluations Demographics history clinical radiological and antibiotic therapy data will be recorded as well as serum urinary and respiratory samples will be collected both on admission and during hospitalization from consenting individuals Patients will be classified as having a CAP-related versus CAP-unrelated failure according to a pathophysiological classification Patients will be also classified as having or not a cardiovascular event either on admission or during hospitalizationThe following outcomes will be measured
1 Incidence timing etiology and risk factors of clinical failure related vs unrelated to CAP 2 Incidence timing and risk factors of cardiovascular events 3time to clinical stability length of hospital stay mortality at hospital discharge and mortality at 30 and 180 days
Detailed Description:
None
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