Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04835818
Status:
UNKNOWN
Last Update Posted:
2021-10-13
First Post:
2021-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2021-04-05', 'studyFirstSubmitQcDate': '2021-04-05', 'lastUpdatePostDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intravenous antibiotic-free day within 14 days', 'timeFrame': 'up to 14 days', 'description': 'days without intravenous antibiotics within 14 days'}], 'secondaryOutcomes': [{'measure': 'ICU stay', 'timeFrame': 'up to 21 days', 'description': 'days of stay in ICU'}, {'measure': 'Antibiotic-free day within 21 days', 'timeFrame': '21 days', 'description': 'days without antibiotics within 21 days'}, {'measure': 'Intravenous antibiotic-free day within 21 days', 'timeFrame': 'up to 21 days', 'description': 'days without intravenous antibiotics within 21 days'}, {'measure': 'Ventilator-free day within 28 days', 'timeFrame': 'up to 28 days', 'description': 'days without intravenous antibiotics within 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Community-acquired Pneumonia', 'Critical Illness', 'Point-of-care'], 'conditions': ['Community-acquired Pneumonia', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center.', 'detailedDescription': 'Point-of-Care Multiplex PCR Testing could narrow down the pathogens causing severe community-acquired pneumonia(CAP). Our hypothesis is that the result of Point-of-Care Multiplex PCR Testing could help primary physician to reduce antibiotics use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age \\>20 y/o)\n* ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis\n* Treatment with endotracheal Intubation\n\nExclusion Criteria:\n\n* Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)\n* Nosocomial infection'}, 'identificationModule': {'nctId': 'NCT04835818', 'briefTitle': 'Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia', 'orgStudyIdInfo': {'id': '201901147RIND'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reporting', 'description': 'check point-of-care Multiplex PCR for pneumonia pathogens and report results to primary care physician', 'interventionNames': ['Diagnostic Test: Provide the panel report to the primary care physician']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'check point-of-care Multiplex PCR for pneumonia pathogens but do NOT report results to primary care physician. Let primary care physician provide usual standard care'}], 'interventions': [{'name': 'Provide the panel report to the primary care physician', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)', 'armGroupLabels': ['Reporting']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Chung Chuang, MD PhD', 'role': 'CONTACT', 'email': 'weischuang@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '65045'}, {'name': 'Ying-Chun Chien, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Wang-Da Liu, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yu-Chung Chuang, MD. PhD', 'role': 'CONTACT', 'email': 'weischuang@gmail.com', 'phone': '886-2-23123456', 'phoneExt': '65045'}, {'name': 'Yu-Chung Chuang, MD. PhD', 'role': 'CONTACT', 'phone': '886-972652532'}], 'overallOfficials': [{'name': 'Yu-Chung Chuang, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}