Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations - Full Text View

Sponsors and Collaborators:	University Hospital, Geneva Ligue Pulmonaire Genevoise
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00448604

Purpose

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.

Condition
Pulmonary Disease, Chronic Obstructive Respiratory Tract Infections Virus Diseases Lung Diseases, Obstructive

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Impact of Viral Infections in Patients With Chronic Obstructive Pulmonary Diseases: Virological Work-up During Exacerbations and 1-Year Follow-up

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Naso-pharyngeal swaps

Estimated Enrollment:	100
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009

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

We aim to

describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD;
explore the evolution of viral infections outside exacerbations;
analyze the impact of viral infections on clinical outcomes;
explore the role of biological markers (CRP, procalcitonin) for the diagnosis and prognosis of viral infections.

Methods

We 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with COPD admitted with acute exacerbation

Criteria

Inclusion Criteria:

All consecutive patients known or suspected for moderate to very severe COPD and admitted in the emergency center for an acute exacerbation of their COPD
Age above 18 years
We plan to include 100 patients with a complete work-up and follow-up
Written informed consent will be obtained from every participant

Exclusion Criteria:

Patients requiring oro-tracheal intubation
Patients unable to give their informed consent due to their clinical condition
Other obvious cause of dyspnea (pulmonary embolism, acute pulmonary edema, lobar pneumonia)
Patients suffering from bronchiectasis, asthma, pulmonary fibrosis and mineral dust pneumoconiosis
Patients with a history of active tuberculosis
Patients with a history of ischemic cerebral stroke and subsequent deglutition dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448604

Locations

Switzerland
Geneva University Hospital
Geneva, Switzerland, 1211

Sponsors and Collaborators

University Hospital, Geneva

Ligue Pulmonaire Genevoise

Investigators

Principal Investigator:

Olivier T Rutschmann, MD, MPH

Geneva University Hospital

More Information

No publications provided

Responsible Party:	HUG, Geneva ( O. Rutschmann )
Study ID Numbers:	06-257
Study First Received:	March 16, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00448604 History of Changes
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:

procalcitonin
acute exacerbation
RT-PCR
Biological Markers

Study placed in the following topic categories:

Virus Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

Lung Diseases
Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Virus Diseases
Communicable Diseases
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases
Respiration Disorders
Chronic Disease
Infection
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 02, 2009