Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 9:17 PM
Study NCT ID:
NCT01265095
Status:
UNKNOWN
Last Update Posted:
2012-08-30
First Post:
2010-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-28', 'studyFirstSubmitDate': '2010-12-10', 'studyFirstSubmitQcDate': '2010-12-21', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all cause inhospital mortality', 'timeFrame': '30days', 'description': 'inhospital mortality as primary outcome, mean length of hospital stay around 30 days'}], 'secondaryOutcomes': [{'measure': 'VRE DNA load', 'timeFrame': '14days', 'description': 'VRE DNA load change during VRE treatment. Pre- and post-treatment compare.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VRE'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that quantitative PCR can be used in VRE bacteremia outcome monitoring. Vancomycin-resistant enterococci (VRE) was first found in 1988 and has become an important healthcare-associated pathogen due to rapid spread, limited options for therapy and the possibility of transferring vancomycin resistance to more virulent pathogens. VRE infections not only contribute to more hospital cost and longer length of hospital stay, but also higher attributable mortality compared to those caused by vancomycin susceptible enterococci. Two different meta-analyses have shown that vancomycin resistance is an independent predictor of death among patients with enterococcal bloodstrem infections (BSIs). Despite this, few effective antibiotics are approved by the US Food and Drug Administration for the treatment of serious VRE infections. Though several studies have conducted to find the possible mortality predictors, but none has used bacterial load as a marker.\n\nSchonheyder et al. have used semiquantitative culture, and demonstrate the relationship between high bacterial load and mortality. However, it may take more than two days before culture result available, and the sensitivity of culture is greatly affected by antimicrobial treatment. Real-time PCR has been demonstrate good performance in early detection of bacteremia, and theoretically is less affected by antimicrobial usage. However, using quantitative real-time PCR to quantify VRE in blood has not been explored, yet.\n\nThe objective of this study is to establish a quantitative method to measure the amounts of VRE in blood using the VRE specific van gene. And test the hypothesis that higher VRE load in blood results in higher mortality among patients with VRE BSIs.\n\nPrimers and probe of VRE Real-time PCR will be constructed first. The investigators will prospective enroll patient with VRE bacteremia. Clinical data and outcome will be monitored. Bacteria load of VRE bacteremia will be measured via established real-time PCR. The outcome and the association of bacteria load of VRE bacteremia will be analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'VRE bacteremia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 y/o\n* VRE bacteremia'}, 'identificationModule': {'nctId': 'NCT01265095', 'briefTitle': 'Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Establish Quantitative PCR to Measure Bacteria Load of the VRE Bacteremia', 'orgStudyIdInfo': {'id': '201011023RB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VRE bacteremia', 'description': 'VRE bacteremia patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'YuChung Chuang, MD', 'role': 'CONTACT', 'email': 'weischuang@gmail.com', 'phone': '886-919121123'}, {'name': 'YuChung Chuang, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'national Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'YuChung Chuang, MD', 'role': 'CONTACT', 'email': 'weischuang@gmail.com', 'phone': '886-919121123'}], 'overallOfficials': [{'name': 'JannTay Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}