Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

Pulmonary Disease, Chronic Obstructive Clinical Trial

— VICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448604
• Other study ID #: 06-257
• Status: Completed
• Phase: N/A
• First received: March 16, 2007
• Last updated: November 3, 2010
• Start date: May 2007
• Est. completion date: September 2009

Study information

• Verified date: February 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Infection
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections
• Virus Diseases

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Ligue Pulmonaire Genevoise

Country where clinical trial is conducted

Switzerland,