Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448604
Status:
COMPLETED
Last Update Posted:
2010-11-04
First Post:
2007-03-16
Brief Title:
Viral Infections in Chronic Obstructive Pulmonary Disease COPD Exacerbations
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Impact of Viral Infections in Patients With Chronic Obstructive Pulmonary Diseases Virological Work-up During Exacerbations and 1-year Follow-up
Status:
COMPLETED
Status Verified Date:
2009-02
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:
VICE
Brief Summary:
The objectives of the study are
to determine the prevalence of respiratory virus infections in COPD patients during and outside acute exacerbation
to explore the impact of these viral infections on the outcome of these patients
to explore the association between blood procalcitonin levels and viral infections in this population
to determine the prevalence of respiratory virus infections in COPD patients during and outside acute exacerbation
to explore the impact of these viral infections on the outcome of these patients
to explore the association between blood procalcitonin levels and viral infections in this population
Detailed Description:
Background
Chronic obstructive pulmonary disease COPD is a leading cause of morbidity due to repeated exacerbations The impact of viral infections during and outside COPD exacerbations is poorly understood and there is only scarce data on the role of new biological markers of infection for the management of COPD exacerbations
Objectives of the project
The investigators aim to
1 describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD
2 explore the evolution of viral infections outside exacerbations
3 analyze the impact of viral infections on clinical outcomes
4 explore the role of biological markers CRP procalcitonin for the diagnosis and prognosis of viral infections
Methods
The investigators will prospectively follow-up 100 patients admitted with an acute exacerbation of their COPD Virological samples will be obtained at admission and at 3 months to explore the evolution outside episodes of acute exacerbation Clinical information will be obtained after one-year follow-up Samples will be tested by RT-PCR for 15 respiratory viruses The impact of viral infections and the role of biological markers will be explored using univariate and multivariate Cox proportional hazard models
Chronic obstructive pulmonary disease COPD is a leading cause of morbidity due to repeated exacerbations The impact of viral infections during and outside COPD exacerbations is poorly understood and there is only scarce data on the role of new biological markers of infection for the management of COPD exacerbations
Objectives of the project
The investigators aim to
1 describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD
2 explore the evolution of viral infections outside exacerbations
3 analyze the impact of viral infections on clinical outcomes
4 explore the role of biological markers CRP procalcitonin for the diagnosis and prognosis of viral infections
Methods
The investigators will prospectively follow-up 100 patients admitted with an acute exacerbation of their COPD Virological samples will be obtained at admission and at 3 months to explore the evolution outside episodes of acute exacerbation Clinical information will be obtained after one-year follow-up Samples will be tested by RT-PCR for 15 respiratory viruses The impact of viral infections and the role of biological markers will be explored using univariate and multivariate Cox proportional hazard models
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