Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-03-01 @ 10:45 PM
Study NCT ID:
NCT02764359
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2016-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-11-19', 'releaseDate': '2024-10-25'}], 'estimatedResultsFirstSubmitDate': '2024-10-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-01-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-01', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-05', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-01-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to attain therapeutic vancomycin concentrations', 'timeFrame': '< 7 days'}], 'secondaryOutcomes': [{'measure': 'Reported adverse events', 'timeFrame': '48 hours post initial vancomycin dose', 'description': "Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso.\n\nNephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements."}, {'measure': 'Examine the pharmacokinetic parameter of elimination rate constant (ke) following the loading vancomycin dose', 'timeFrame': '12 hours'}, {'measure': 'Examine the pharmacokinetic parameter of volume of distribution (Vd) following the loading vancomycin dose', 'timeFrame': '12 hours'}, {'measure': 'Intensive care unit length of stay', 'timeFrame': '30 days'}, {'measure': 'Hospital length of stay', 'timeFrame': '30 days'}, {'measure': 'In-hospital mortality', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infection', 'Sepsis', 'Obesity']}, 'descriptionModule': {'briefSummary': "Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial.\n\nThis research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department\n* Weight \\>100kg\n* Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital\n\nExclusion Criteria:\n\n* Any patient \\<18 years of age\n* Patients on dialysis or with unstable renal function (a change of \\>0.5 mg/dL in SCr concentration in patients with a SCr of \\<2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)'}, 'identificationModule': {'nctId': 'NCT02764359', 'briefTitle': 'Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens', 'organization': {'class': 'OTHER', 'fullName': 'CAMC Health System'}, 'officialTitle': 'Single-Center Prospective Study of Obese Patients Comparing Two Vancomycin Loading Dose Regimens', 'orgStudyIdInfo': {'id': '15-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV Vancomycin loading dose- higher', 'description': 'IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg', 'interventionNames': ['Drug: IV vancomycin']}, {'type': 'EXPERIMENTAL', 'label': 'IV Vancomycin loading dose- lower', 'description': 'IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg', 'interventionNames': ['Drug: IV vancomycin']}], 'interventions': [{'name': 'IV vancomycin', 'type': 'DRUG', 'description': 'IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.', 'armGroupLabels': ['IV Vancomycin loading dose- higher', 'IV Vancomycin loading dose- lower']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25304', 'city': 'Charleston', 'state': 'West Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Payne, MD', 'role': 'CONTACT', 'email': 'Murnau@aol.com', 'phone': '304-388-6004'}, {'name': 'Adam Crawford, DO', 'role': 'CONTACT', 'email': 'acrawford@osteo.wvsom.edu', 'phone': '304-388-6004'}, {'name': 'William Payne, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Adam Crawford, DO', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CAMC Health Systems', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'centralContacts': [{'name': 'William Payne, MD', 'role': 'CONTACT', 'email': 'Murnau@aol.com', 'phone': '304-388-6004'}, {'name': 'Adam Crawford, DO', 'role': 'CONTACT', 'email': 'acrawford@osteo.wvsom.edu', 'phone': '304-388-6004'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CAMC Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emergency Medicine Physician', 'investigatorFullName': 'William Payne', 'investigatorAffiliation': 'CAMC Health System'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-25', 'type': 'RELEASE'}, {'date': '2024-11-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'CAMC Health System'}}}}