Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-06 @ 2:07 PM
Study NCT ID:
NCT03280004
Status:
UNKNOWN
Last Update Posted:
2019-04-29
First Post:
2017-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reason Evaluation of Initial Treatment Failure in Patients With CAP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077266', 'term': 'Moxifloxacin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 314}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-26', 'studyFirstSubmitDate': '2017-09-10', 'studyFirstSubmitQcDate': '2017-09-10', 'lastUpdatePostDateStruct': {'date': '2019-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'early deterioration or progression rate', 'timeFrame': '3 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Community-acquired Pneumonia']}, 'descriptionModule': {'briefSummary': 'This research is to evaluate the effect of different antibiotics (Moxifloxacin Hydrochloride and Sodium Chloride Injection vs. β-lactam antibiotics for injection +/- Azithromycin for Injection) on the early deterioration or progression (\\<72 h of treatment) of community acquired pneumonia and to study the effect of the early deterioration or progression on the prognosis of community acquired pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients in the 17 centers of the study who meet the inclusion and exclusion criteria will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>=18y.\n2. Diagnosed with CAP.\n3. Need hospitalization.\n4. Receive Moxifloxacin Hydrochloride and Sodium Chloride Injection or β-lactam antibiotics for injection +/- Azithromycin for Injection as initial treatment.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be included in the study:\n\n1. Pneumonia is aquired more than 48h after admission or the patient was admitted to hospital within 30 days prior to admission.\n2. Start antibiotic treatment before admission.\n3. Gestational period or suckling period.\n4. Admitted to ICU.\n5. Immunocompromised patients.\n6. Pneumonia is the terminal event of a serious disease.\n7. Tuberculosis, lung cancer, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmanory eosinophilia, pulmonary vasculitis.\n8. Allergic to the antibiotics of the study.'}, 'identificationModule': {'nctId': 'NCT03280004', 'acronym': 'RECAP', 'briefTitle': 'Reason Evaluation of Initial Treatment Failure in Patients With CAP', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Reason Evaluation of Initial Treatment Failure in Patients With Community Acquired Pneumonia', 'orgStudyIdInfo': {'id': 'HS-1279'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Moxifloxacin group', 'interventionNames': ['Drug: Moxifloxacin Hydrochloride and Sodium Chloride Injection']}, {'label': 'β-lactams group'}], 'interventions': [{'name': 'Moxifloxacin Hydrochloride and Sodium Chloride Injection', 'type': 'DRUG', 'description': 'Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection.', 'armGroupLabels': ['Moxifloxacin group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Xu, MD', 'role': 'CONTACT', 'email': 'xujunfree@126.com', 'phone': '01069159142', 'phoneExt': '01069159142'}], 'facility': 'Jun Xu', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Xu, MD', 'role': 'CONTACT', 'email': 'xujunfree@126.com', 'phone': '010-69159142'}], 'overallOfficials': [{'name': 'Xuezhong Yu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Jun Xu', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}