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Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations (VICE)

This study has been completed.
Sponsor:
Collaborator:
Ligue Pulmonaire Genevoise
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00448604
First received: March 16, 2007
Last updated: November 3, 2010
Last verified: February 2009
History of Changes
  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: Observational Model: Cohort
Time Perspective: 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:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Biospecimen Retention:   Samples Without DNA

Naso-pharyngeal swaps


Enrollment: 86
Study Start Date: May 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  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 by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: O. Rutschmann, HUG, Geneva
ClinicalTrials.gov Identifier: NCT00448604     History of Changes
Other Study ID Numbers: 06-257
Study First Received: March 16, 2007
Last Updated: November 3, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
procalcitonin
acute exacerbation
RT-PCR
Biological Markers

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Infections
Virus Diseases
 Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Infection

ClinicalTrials.gov processed this record on May 23, 2013