Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-01 @ 10:38 AM
Study NCT ID:
NCT00448604
Status:
COMPLETED
Last Update Posted:
2010-11-04
First Post:
2007-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Naso-pharyngeal swaps'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-03', 'studyFirstSubmitDate': '2007-03-16', 'studyFirstSubmitQcDate': '2007-03-16', 'lastUpdatePostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['procalcitonin', 'acute exacerbation', 'RT-PCR', 'Biological Markers'], 'conditions': ['Pulmonary Disease, Chronic Obstructive', 'Respiratory Tract Infections', 'Virus Diseases', 'Lung Diseases, Obstructive']}, 'referencesModule': {'references': [{'pmid': '20435659', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of the study are\n\n* to determine the prevalence of respiratory virus infections in COPD patients, during and outside acute exacerbation\n* to explore the impact of these viral infections on the outcome of these patients\n* to explore the association between blood procalcitonin levels and viral infections in this population.', 'detailedDescription': 'Background\n\nChronic 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.\n\nObjectives of the project\n\nThe investigators aim to\n\n1. describe the epidemiology of viral infections in patients admitted with an exacerbation of their COPD;\n2. explore the evolution of viral infections outside exacerbations;\n3. analyze the impact of viral infections on clinical outcomes;\n4. explore the role of biological markers (CRP, procalcitonin) for the diagnosis and prognosis of viral infections.\n\nMethods\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with COPD admitted with acute exacerbation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Age above 18 years\n* We plan to include 100 patients with a complete work-up and follow-up\n* Written informed consent will be obtained from every participant\n\nExclusion Criteria:\n\n* Patients requiring oro-tracheal intubation\n* Patients unable to give their informed consent due to their clinical condition\n* Other obvious cause of dyspnea (pulmonary embolism, acute pulmonary edema, lobar pneumonia)\n* Patients suffering from bronchiectasis, asthma, pulmonary fibrosis and mineral dust pneumoconiosis\n* Patients with a history of active tuberculosis\n* Patients with a history of ischemic cerebral stroke and subsequent deglutition dysfunction'}, 'identificationModule': {'nctId': 'NCT00448604', 'acronym': 'VICE', 'briefTitle': 'Viral Infections in Chronic Obstructive Pulmonary Disease (COPD) Exacerbations', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Impact of Viral Infections in Patients With Chronic Obstructive Pulmonary Diseases: Virological Work-up During Exacerbations and 1-year Follow-up', 'orgStudyIdInfo': {'id': '06-257'}}, 'contactsLocationsModule': {'locations': [{'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Geneva University Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Olivier T Rutschmann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ligue Pulmonaire Genevoise', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'O. Rutschmann', 'oldOrganization': 'HUG, Geneva'}}}}