Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-03-03 @ 11:54 PM
Study NCT ID:
NCT04088305
Status:
COMPLETED
Last Update Posted:
2022-08-31
First Post:
2019-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vancomycin Dosage Strategy Based on a Trough Concentration Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011023', 'term': 'Pneumonia, Staphylococcal'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018410', 'term': 'Pneumonia, Bacterial'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2019-09-07', 'studyFirstSubmitQcDate': '2019-09-11', 'lastUpdatePostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of vancomycin therapeutic serum trough concentrations', 'timeFrame': 'before the fifth vancomycin dosage', 'description': 'The proportion of patients with vancomycin serum trough concentrations reaching target concentrations (≥15mg/L)will be compared between study group and control group'}], 'secondaryOutcomes': [{'measure': 'Clinical success rate', 'timeFrame': 'Seven days after vancomycin withdrawal.', 'description': 'the proportion of patients with clinical success'}, {'measure': 'Vancomycin doses', 'timeFrame': 'At the end of vancomycin therapy, an average of 10 days.', 'description': 'Vancomycin daily doses and totally doses'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': 'At the end of vancomycin treatment, an average of 10 days.', 'description': 'The incidence of vancomycin-associated acute kidney injury'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pneumonia', 'vancomycin', 'trough concentration', 'elderly patients'], 'conditions': ['Pneumonia, Staphylococcal']}, 'descriptionModule': {'briefSummary': 'Study design:\n\nAllocation: Randomized Endpoint classification: Efficacy study Masking: Open label Primary purpose: Treatment Primary endpoint: Incidence of reaching the target serum trough concentration Secondary endpoint: Clinical efficiency, Antibiotic use, acute kidney injury.', 'detailedDescription': 'This is a prospective randomized control trial. There are two groups, study group and control group. Patients of study group accepted vancomycin strategies decided by a serum trough concentration model, and patients of control group accepted vancomycin dosage decided by attending physician. The primary endpoint is the incidence of reaching the target serum trough concentration, the secondary endpoint are clinical efficiency, antibiotic use and side effects such as acute kidney injury, etc.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with doubted or diagnosed Methicillin-resistant Staphylococcus aureus severe pneumonia, and need vancomycin treatment.\n* Sixty years and older.\n\nExclusion Criteria:\n\n* younger than 60 years old\n* Accepted blood purification therapy\n* Pregnancy\n* Positive HIV antibody titre\n* Had known or suspected tuberculosis or other infections caused by fungi at baseline.'}, 'identificationModule': {'nctId': 'NCT04088305', 'briefTitle': 'Vancomycin Dosage Strategy Based on a Trough Concentration Model', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Clinical Evaluation of a Vancomycin Dosage Strategy Based on a Serum Trough Concentration Model in Elderly Patients With Severe Pneumonia', 'orgStudyIdInfo': {'id': 'Y75505-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Patients of study group will accept vancomycin strategies decided by a serum trough concentration model.', 'interventionNames': ['Drug: Individualized therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients of control group will accept vancomycin dosages decided by attending physician.'}], 'interventions': [{'name': 'Individualized therapy', 'type': 'DRUG', 'otherNames': ['Vancomycin'], 'description': 'Dosage of Vancomycin decided by a serum trough concentration model, instead of decided by attending physician', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Third Hospita', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Qingtao Zhou, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qingtao Zhou', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}