Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:53 PM
Study NCT ID:
NCT05762094
Status:
UNKNOWN
Last Update Posted:
2023-03-15
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study on Personalized Dosing Strategy of Patients Treated by Carbapenems: 2018-2021
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-13', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'January 2018-December 2021', 'description': '30-day mortality and 90-day mortality'}, {'measure': 'Attainment of Target Trough Concentration', 'timeFrame': 'January 2018-December 2021', 'description': 'Attainment of Target Trough Concentration'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients reach clinical response at end of treatment', 'timeFrame': 'January 2018-December 2021', 'description': 'By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\\*10\\^9/L or less than 4\\*10\\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms'}, {'measure': 'Proportion of patients reach clinical response at day 4 of treatment', 'timeFrame': 'January 2018-December 2021', 'description': 'By definition, a successful clinical response means resolution of clinically significant signs and symptoms(defined as any criteria of systemic inflammatory response syndrome, body temperature over 38℃ or below 36℃, blood white cell count more than 12\\*10\\^9/L or less than 4\\*10\\^9/L, respiratory rate faster than 20 times per minute and heart rate higher than 90 beats per minute) or partial resolution of clinically significant signs and symptoms'}, {'measure': 'Daily Sequential Organ Failure Assessment score change', 'timeFrame': 'January 2018-December 2021', 'description': 'Sequential Organ Failure Assessment score (Range from 0-24), lower score means a better outcome. Increase of 2 points within 48 hours means the presence of sepsis.'}, {'measure': 'Incidence of Septic Shock', 'timeFrame': 'January 2018-December 2021', 'description': 'Incidence of Septic Shock'}, {'measure': 'Safety outcome measures', 'timeFrame': 'January 2018-December 2021', 'description': 'Safety outcome measures including nephrotoxicity, hepatotoxicity and other adverse events related to the antibiotic treatment of carbapenems'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carbapenem', 'Bacterial Infections'], 'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'Patients may benefit from the personalized carbapenem dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review and analyze the clinical outcomes of patients with different dosing strategy.', 'detailedDescription': 'Rational use of carbapenem is closely associated with the clinical outcome of patients with infections. Serum concentration of carbapenem varies from different populations. The objective of this study is to describe the clinical outcome of patients with infection treated by carbapenem in China, regarding diagnosis, treatment and follow-up. It is a single-center, retrospective, descriptive study. Inclusion criteria are an age ≥ 18, diagnosed as bacteria infection and serum concentration must be determined during therapy. Data concerning clinical presentation, biological samples, treatment and follow-up will be assessed. A descriptive analysis will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chinese adult patients with bacterial infections treated by carbapenem', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge over 18 years Chinese patient: male or female Diagnosed as bacterial infection Treated by carbapenem Serum concentration determined during therapy\n\nExclusion Criteria:\n\nDuration of carbapenem treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of carbapenem'}, 'identificationModule': {'nctId': 'NCT05762094', 'briefTitle': 'A Retrospective Study on Personalized Dosing Strategy of Patients Treated by Carbapenems: 2018-2021', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'A Retrospective Study on Personalized Dosing Strategy of Patients With Bacterial Infections Treated by Carbapenems From a Tertiary Medical Center During 2018-2021', 'orgStudyIdInfo': {'id': '2022-504-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CAR-R', 'description': 'Patients with impaired renal function (eGFR \\< 60ml/min/1.73m2) treated by carbapenem'}, {'label': 'CAR-L', 'description': 'Patients with liver cirrhosis or impaired liver function (Child-Pugh grade B or C) treated by carbapenem'}, {'label': 'CAR-LR', 'description': 'Patients with co-morbidity of both liver cirrhosis or impaired liver function (Child-Pugh grade B or C) and impaired renal function (eGFR \\< 60ml/min/1.73m2) treated by carbapenem'}, {'label': 'CAR-N', 'description': 'Patients with normal liver function or renal function treated by carbapenem'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dayu Chen', 'role': 'CONTACT', 'email': 'cdy_pharmacy@njglyy.com', 'phone': '+86-025-83106666-60921'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}