Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-02 @ 5:49 AM
Study NCT ID:
NCT00035269
Status:
COMPLETED
Last Update Posted:
2011-04-26
First Post:
2002-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011018', 'term': 'Pneumonia, Pneumococcal'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}], 'ancestors': [{'id': 'D011008', 'term': 'Pneumococcal Infections'}, {'id': 'D013290', 'term': 'Streptococcal Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-12'}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-25', 'studyFirstSubmitDate': '2002-05-02', 'studyFirstSubmitQcDate': '2002-05-02', 'lastUpdatePostDateStruct': {'date': '2011-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the microbiologic efficacy of linezolid in the treatment of patients with pneumonia caused by penicillin-resistant Streptococcus pneumoniae (PRSP).'}, {'measure': 'Additionally, microbiologic efficacy will be assessed in all pneumonia patients infected with S pneumoniae SP) and in those infected with penicillin-sensitive (PSSP) and penicillin-intermediate (PISP) S pneumoniae.'}], 'secondaryOutcomes': [{'measure': 'To assess clinical efficacy and safety in pneumonia patients infected with S pneumoniae.'}]}, 'conditionsModule': {'keywords': ['Pharmacia'], 'conditions': ['Pneumonia, Pneumococcal', 'Community Acquired Infections', 'Gram-positive Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'This study will treat patients who have a community-acquired pneumonia that is due to a specific bacteria (S. pneumoniae)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.\n\nInclusion Criteria:\n\n* Patients must have the signs and symptoms of pneumonia, with a chest xray showing a pneumonia.\n* The patient must have S. pneumoniae (a specific bacteria) growing in sputum or blood to continue treatment.\n\nExclusion Criteria:\n\n* Patients cannot have taken more than one day of another antibiotic before entering this study.\n* Patients with HIV and a low CD4 count are excluded.'}, 'identificationModule': {'nctId': 'NCT00035269', 'briefTitle': 'New Antibiotic to Treat Patients With Community-acquired Pneumonia Due to a Specific Bacteria (S. Pneumoniae Pneumonia)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Linezolid in the Treatment of Penicillin-Resistant Streptococcus Pneumoniae Pneumonia: An Open-Label, Non-Comparator Study', 'orgStudyIdInfo': {'id': 'M12600071'}, 'secondaryIdInfos': [{'id': 'A5951056'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Antibiotic', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '31416', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48197', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07102', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '08876', 'city': 'Somerville', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.57427, 'lon': -74.60988}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43701', 'city': 'Zanesville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 39.94035, 'lon': -82.01319}}, {'zip': '19522', 'city': 'Fleetwood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.45398, 'lon': -75.81798}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '29666', 'city': 'Ninety Six', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 34.17513, 'lon': -82.02401}}, {'zip': '29307', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 34.94957, 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{'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79430', 'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23294', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Bratislava', 'country': 'Slovakia', 'facility': 'Research Center', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '17007', 'city': 'Girona', 'state': 'Girona', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28923', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28935', 'city': 'Móstoles', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Research Center', 'geoPoint': {'lat': 40.32234, 'lon': -3.86496}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Research Center', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Research Center', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}