Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-02-24 @ 2:09 PM
Study NCT ID:
NCT01600768
Status:
UNKNOWN
Last Update Posted:
2012-05-17
First Post:
2012-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047090', 'term': 'beta-Lactams'}], 'ancestors': [{'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-16', 'studyFirstSubmitDate': '2012-05-16', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum concentrations of beta-lactams', 'timeFrame': '6 hours', 'description': 'Determination of serum concentrations of beta-lactams'}]}, 'conditionsModule': {'keywords': ['focus of study'], 'conditions': ['Gram-Negative Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\> 18 years)\n* Admitted on the intensive care unit\n* Starting a treatment with beta-lactams antibiotics\n* Signed informed consent\n* Expected to live \\> 3 days\n\nExclusion Criteria:\n\n* renal insufficiency (estimated clearance \\< 20 ML /MIN)\n* renal replacement therapy\n* ANC \\< 1000 103 µl\n* pregnancy\n* drug abuse'}, 'identificationModule': {'nctId': 'NCT01600768', 'briefTitle': 'Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'orgStudyIdInfo': {'id': '200912104M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intermittent infusion', 'interventionNames': ['Drug: Beta-Lactams']}, {'type': 'EXPERIMENTAL', 'label': 'extended infusion', 'interventionNames': ['Drug: Beta-Lactams']}], 'interventions': [{'name': 'Beta-Lactams', 'type': 'DRUG', 'description': 'infusion time: 30 mins or 1 hr', 'armGroupLabels': ['intermittent infusion']}, {'name': 'Beta-Lactams', 'type': 'DRUG', 'description': 'infusion time 4 hrs', 'armGroupLabels': ['extended infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shu-Wen Lin, Pharm D.', 'role': 'CONTACT', 'email': 'shuwenlin@ntu.edu.tw', 'phone': '(02)2312-3456', 'phoneExt': '88372'}], 'facility': 'NTUH', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shu-Wen Lin, Pharm D.', 'role': 'CONTACT', 'email': 'shuwenlin@ntu.edu.tw', 'phone': '(02)2312-3456', 'phoneExt': '88372'}], 'overallOfficials': [{'name': 'Shu-Wen Lin, Pharm D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}