Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-10 @ 8:19 AM
Study NCT ID:
NCT02822950
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2016-06-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
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Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.\n\nCeftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftazadime/Avibactam', 'description': 'Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \\[other antibiotics can also be administered as needed\\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.\n\nCeftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2,4,6, 8 hours after receiving the drug', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ceftazadime/Avibactam', 'description': 'Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \\[other antibiotics can also be administered as needed\\]. 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Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.\n\nCeftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2,4,6, 8 hours after receiving the drug', 'unitOfMeasure': 'mg/liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ceftazadime/Avibactam', 'description': 'Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \\[other antibiotics can also be administered as needed\\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.\n\nCeftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ceftazadime/Avibactam', 'description': 'Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \\[other antibiotics can also be administered as needed\\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.\n\nCeftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-04', 'size': 464611, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-03-26T09:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-09', 'studyFirstSubmitDate': '2016-06-28', 'resultsFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2016-07-05', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-09', 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Volume of Distribution Parameter in Intensive Care Patients', 'timeFrame': '2,4,6, 8 hours after receiving the drug'}, {'measure': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Half Life Parameter in Intensive Care Patients', 'timeFrame': '2,4,6, 8 hours after receiving the drug'}, {'measure': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Clearance of Drug Parameter in Intensive Care Patients', 'timeFrame': '2,4,6, 8 hours after receiving the drug'}, {'measure': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic Area Under Serum Curve (mg*h/L) Parameter in Intensive Care Patients', 'timeFrame': '2,4,6, 8 hours after receiving the drug'}, {'measure': 'Mean (SD) Ceftazadime/Avibactam Pharmacokinetic (PK) Maximum Serum Concentration in Intensive Care Patients', 'timeFrame': '2,4,6, 8 hours after receiving the drug'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pharmacokinetics of Avycaz in ICU Patients']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to analyze the PK/PD of AvyCaz in critically ill patients in the Intensive Care Unit (12). This study will include medical and post-surgical patients who develop an infection where Avycaz can be utilized. Since these patients will have variable PK parameters, the investigators will also analyze (time-kill) these serum concentrations (ex vivo) against relevant clinical isolates (e.g. GNR with ESBL or KPC) from the ICU to determine microbiologic activity of Avycaz in critically ill patients with variable characteristics. Monte-Carlo simulations will also be conducted against clinical ICU isolates (JMI labs) to help determine appropriate dosing schedules based upon these PK parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, IA infections and pneumonia (including VAP)\n* Patients requiring intensive care (critically ill patients) in the med/surg ICU (APACHE II score ≥ 15)\n* Patients prescribed Avycaz for their infection will receive FDA recommended dosages and times of administration\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant Patients, patients older than 90 y/o, those with CrCl \\< 30 mL/min, patients with a BMI \\> 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study'}, 'identificationModule': {'nctId': 'NCT02822950', 'briefTitle': 'A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Michigan State University'}, 'officialTitle': 'A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'IIT-USA-000832'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ceftazadime/avibactam', 'description': 'Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours \\[other antibiotics can also be administered as needed\\]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.', 'interventionNames': ['Drug: Ceftazidime/avibactam']}], 'interventions': [{'name': 'Ceftazidime/avibactam', 'type': 'DRUG', 'otherNames': ['Avycaz'], 'description': 'Ceftazadime/avibactam dosing in ICU patients', 'armGroupLabels': ['Ceftazadime/avibactam']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Gary E Stein, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michigan State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Gary E. Stein, Pharm.D.', 'investigatorAffiliation': 'Michigan State University'}}}}