Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-03-24 @ 11:29 AM
Study NCT ID:
NCT00987792
Status:
COMPLETED
Last Update Posted:
2015-08-07
First Post:
2009-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2595}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2009-09-30', 'studyFirstSubmitQcDate': '2009-09-30', 'lastUpdatePostDateStruct': {'date': '2015-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective is to evaluate the distribution of the CRB-65 severity index at baseline in hospitalized patients suffering from CAP and to whom moxifloxacin (starting with intravenous administration) was prescribed, in countries from South Eastern', 'timeFrame': 'At baseline only'}], 'secondaryOutcomes': [{'measure': 'Assessment of use of different diagnostic measures in daily routine practice, especially chest radiography and microbiology', 'timeFrame': '7-14 days'}, {'measure': 'Determination of the proportion of patients treated with moxifloxacin as antibiotic second-line therapy', 'timeFrame': '7-14 days'}, {'measure': 'Assessment of clinical signs and symptoms before and after therapy with moxifloxacin', 'timeFrame': '7-14 days'}, {'measure': 'Measurement of moxifloxacin treatment success in terms of effectiveness and outcome', 'timeFrame': '7-14 days'}, {'measure': 'Evaluation of safety and tolerability of moxifloxacin in hospitalized CAP patients', 'timeFrame': '7-14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Community Acquired Pneumonia'], 'conditions': ['Pneumonia']}, 'referencesModule': {'references': [{'pmid': '24975809', 'type': 'RESULT', 'citation': 'Kuzman I, Bezlepko A, Kondova Topuzovska I, Rokusz L, Iudina L, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in community acquired pneumonia: a prospective, multicenter, observational study (CAPRIVI). BMC Pulm Med. 2014 Jun 30;14:105. doi: 10.1186/1471-2466-14-105.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to obtain data from hospitalized Community Acquired Pneumonia (CAP) patients on the disease including disease severity, clinical signs and symptoms and measures used for diagnosis in daily routine practice as well as data on Avelox® including information on the use, effectiveness, treatment outcome, safety and tolerability.\n\nAs this is a non-interventional observational study, routine clinical practice is observed. The application of medications follows the normal routines and is decided by the treating physician under recognition of the package insert.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male hospitalized adult patients scheduled to be treated with moxifloxacin for their CAP and starting treatment with intravenous administration will be documented after the attending physician made the therapeutic decision at his/her discretion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult hospitalized patients with a diagnosis of CAP (based on local medical practice) and decision taken by the investigator to treat with moxifloxacin and to start treatment with intravenous administration. The local moxifloxacin product information must be considered.\n\nExclusion Criteria:\n\n* Contraindications stated in the local moxifloxacin product information; warnings and precautions must be considered.'}, 'identificationModule': {'nctId': 'NCT00987792', 'briefTitle': 'CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'CAPRIVI: Community Acquired Pneumonia: Treatment With Avelox® in Hospitalized Patients', 'orgStudyIdInfo': {'id': '14522'}, 'secondaryIdInfos': [{'id': 'AX0801', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Moxifloxacin (Avelox, BAY12-8039)']}], 'interventions': [{'name': 'Moxifloxacin (Avelox, BAY12-8039)', 'type': 'DRUG', 'description': 'Hospitalized patients receiving Avelox according to local drug information', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Many Locations', 'country': 'Croatia'}, {'city': 'Many Locations', 'country': 'France'}, {'city': 'Many Locations', 'country': 'Hungary'}, {'city': 'Many Locations', 'country': 'Jordan'}, {'city': 'Many Locations', 'country': 'Kazakhstan'}, {'city': 'Many Locations', 'country': 'Lebanon'}, {'city': 'Many Locations', 'country': 'Moldova'}, {'city': 'Many Locations', 'country': 'North Macedonia'}, {'city': 'Many Locations', 'country': 'Romania'}, {'city': 'Many Locations', 'country': 'Russia'}, {'city': 'Many Locations', 'country': 'Ukraine'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}