Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-09 @ 5:44 AM
Study NCT ID:
NCT06528028
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2024-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'A non-blind study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Treatment group and control group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-29', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical effective rate', 'timeFrame': '14 days', 'description': "According to the Technical Guidelines for Clinical Trials of Antimicrobial Drugs, clinical efficacy is defined as: (1) effective: symptoms, signs, pathogenic microbiology and various tests and examination indicators are significantly improved;(2) Ineffective: the patient's condition has not improved or worsened, and other antibacterial drugs need to be replaced.Effective rate = Number of effective cases/total cases x 100%."}], 'secondaryOutcomes': [{'measure': 'Bacterial removal', 'timeFrame': '14 days', 'description': 'Defined as clearance or change of existing bacteria within two weeks of medication.'}, {'measure': '28-d mortality', 'timeFrame': '28 days', 'description': 'Defined as whether a patient died at 28-d after follow-up.28-d Mortality rate = Number of deaths/group size x 100%.'}, {'measure': 'PK/PD compliance rate', 'timeFrame': '14 days', 'description': 'PK/PD compliance rate = number of qualified persons/number of groups × 100%.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anti-Infective Agent'], 'conditions': ['Anti-Infective Agent']}, 'descriptionModule': {'briefSummary': 'Ceftazidime/avibactam (CAZ/AVI) is a new β-lactam drug, which has good antibacterial effect against carbapenem resistant enterobacter. However, previous studies found that CAZ/AVI had a low PK/PD compliance rate after the recommended dose of the drug instructions.Therefore, this study was intended to explore the clinical efficacy of different administration schedules of CAZ/AVI for patients with severe infection, and further analyze the correlation between CAZ/AVI PK/PD parameters and clinical efficacy and adverse reactions.', 'detailedDescription': '1. Main purpose The main objective of this study was to verify that the clinical efficacy of treatment group (load dose of 2.5g, then continuous infusion of 2.5gQ8h, the dose can be adjusted according to renal function) with severe infection was superior to that of the control group (standard dose and administration regimen of ceftazidime/avibactam, i.e. 2.5gQ8h, 2h infusion).Dose can be adjusted according to renal function).\n2. Secondary purpose (1) To investigate the relationship between different administration regimens and bacterial clearance and 28-d mortality (2) To explore the correlation between different dosing regimens and PK/PD compliance rate (3) To explore the correlation between different administration regimens and adverse drug reactions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMultiple-resistant negative bacteria Sensitive to ceftazidime/avibactam Received intravenous infusion of ceftazidime/avibactam\n\nExclusion Criteria:\n\nAllergic to ceftazidime/avibactam Blood sample not be collected Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT06528028', 'briefTitle': 'Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes in Patients With Severe Infection: a Multicenter, Prospective, Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'EH3420202401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment group', 'description': 'Ceftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.） loading dose of 2.5g (2h infusion), then the standard dose and administration schedule, namely 2.5gQ8h, continuous infusion, the dose can be adjusted according to the instructions of renal function，The duration of medication is determined by the clinician', 'interventionNames': ['Drug: CAZ/AVI']}, {'type': 'EXPERIMENTAL', 'label': 'control group', 'description': 'Ceftazidime/avibactam（Taidingping®, Qilu Pharmaceutical Co., Ltd.）were given a load dose of 2.5g (2h infusion), followed by 2.5gQ8h, the dose can be adjusted according to renal function.The duration of medication is determined by the clinician.', 'interventionNames': ['Drug: CAZ/AVI']}], 'interventions': [{'name': 'CAZ/AVI', 'type': 'DRUG', 'otherNames': ['Continous group'], 'description': 'continuous infusion is used', 'armGroupLabels': ['treatment group']}, {'name': 'CAZ/AVI', 'type': 'DRUG', 'otherNames': ['Intermittent group'], 'description': '2h-infusion is used', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Xu, Ph.D', 'role': 'CONTACT', 'email': 'ctboycm@hotmail.com', 'phone': '+86 13809043146'}], 'facility': 'Intensive Care Unit, Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Ying Xu, Ph.D', 'role': 'CONTACT', 'email': 'ctboycm@hotmail.com', 'phone': '0086+（025）83106666'}], 'overallOfficials': [{'name': 'Ying Xu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}