Pulmonary Disease, Chronic ObstructiveVICENCT00448604
Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
An observational study of Pulmonary Disease, Chronic Obstructive and Respiratory Tract Infections, run by University Hospital, Geneva at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Infections, Virus Diseases
- How many people
- 86 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD admitted with acute exacerbation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospital
Geneva, Canton of Geneva, 1211
About this study
Official title: 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.
Read the 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
- 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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Infections, Virus Diseases, Lung Diseases, Obstructive
- Keywords
- procalcitonin, acute exacerbation, RT-PCR, Biological Markers
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Infections, Virus Diseases, Lung Diseases, Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue Pulmonaire Genevoise
- Investigators
- Olivier T Rutschmann, MD, MPH, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448604
- Sponsor's protocol ID
- 06-257
- Acronym
- VICE
- Status last verified
- Feb 2009
- First submitted
- 16 Mar 2007
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kherad O, Kaiser L, Bridevaux PO, Sarasin F, Thomas Y, Janssens JP, Rutschmann OT. Upper-respiratory viral infection, biomarkers, and COPD exacerbations. Chest. 2010 Oct;138(4):896-904. doi: 10.1378/chest.09-2225. Epub 2010 Apr 30.
PubMed 20435659
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Viral Infections in Patients With Chronic Obstructive Pulmonary Diseases: Virological Work-up During Exacerbations and 1-year Follow-up
- ClinicalTrials.gov ID
- NCT00448604
- Acronym / sponsor ID
- VICE / 06-257
- Conditions
- Pulmonary Disease, Chronic Obstructive, Respiratory Tract Infections, Virus Diseases, Lung Diseases, Obstructive
- Keywords
- procalcitonin, acute exacerbation, RT-PCR, Biological Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Ligue Pulmonaire Genevoise
- Study start
- May 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD admitted with acute exacerbation
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2010.
- Derived from this study: PubMed 20435659Kherad O, Kaiser L, Bridevaux PO, Sarasin F, Thomas Y, Janssens JP, Rutschmann OT. Upper-respiratory viral infection, biomarkers, and COPD exacerbations. Chest. 2010 Oct;138(4):896-904. doi: 10.1378/chest.09-2225. Epub 2010 Apr 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier T Rutschmann, MD, MPH principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Respiratory Tract Infections, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00448604, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010.