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

November 3, 2010 updated by: University Hospital, Geneva

Impact of Viral Infections in Patients With Chronic Obstructive Pulmonary Diseases: Virological Work-up During Exacerbations and 1-year Follow-up

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Geneva University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with COPD admitted with acute exacerbation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Collaborators

Ligue Pulmonaire Genevoise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 16, 2007

First Submitted That Met QC Criteria

March 16, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

November 4, 2010

Last Update Submitted That Met QC Criteria

November 3, 2010

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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