Ignite Creation Date:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00952861
Status:
WITHDRAWN
Last Update Posted:
2010-08-11
First Post:
2009-07-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'whyStopped': 'Stopped due to poor recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-08-10', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-08-03', 'lastUpdatePostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minutes walking distance', 'timeFrame': 'Day 14'}], 'secondaryOutcomes': [{'measure': 'Time to next episode of acute exacerbation', 'timeFrame': 'Days 14, 30, 90 and 180'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic obstructive pulmonary disease', 'Infection', 'Antibiotics'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 50 years\n* History of smoking\n* History of COPD\n* Antibiotics for 24 hours\n* At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence\n* Informed consent\n\nExclusion Criteria:\n\n* Pneumonia\n* Antibiotics for more than 36 hours\n* Antibiotics for other infection\n* Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days\n* Malignancy\n* Other pulmonary disease\n* Immune deficiency\n* Not able to tolerate doxycycline\n* Severe heart, liver or kidney disease\n* Epilepsia\n* Not stable 24 hours after hospital admission\n* Need for assisted ventilation'}, 'identificationModule': {'nctId': 'NCT00952861', 'acronym': 'TAExaCOP', 'briefTitle': 'Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Antibiotic Treatment of Patients Admitted to Hospital With Acute Exacerbation of COPD. Effect of 1 Day of Antibiotic Therapy Compared to 6 Days of Therapy in Patients Who Are Stable After 24 Hours', 'orgStudyIdInfo': {'id': 'OUH-INF-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Doxycycline', 'description': 'Doxycycline 200 mg QD in 5 days', 'interventionNames': ['Drug: Doxycycline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo QD i 5 days', 'interventionNames': ['Drug: Placebo (matching)']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'description': '200 mg QD in 5 days', 'armGroupLabels': ['Doxycycline']}, {'name': 'Placebo (matching)', 'type': 'DRUG', 'description': 'Placebo QD i 5 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Court Pedersen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kolding Sygehus', 'class': 'OTHER'}, {'name': 'Svendborg Hospital', 'class': 'OTHER'}, {'name': 'Fredericia Hospital', 'class': 'UNKNOWN'}, {'name': 'Naestved Hospital', 'class': 'OTHER'}, {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Region Syddanmark', 'class': 'OTHER'}, {'name': 'Danmarks Lungeforening', 'class': 'OTHER'}, {'name': 'Danish National Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Court Pedersen / professor', 'oldOrganization': 'Department of Infectious Diseases, Odense University Hospital'}}}}