Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT03985605
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2019-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI
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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-30', 'studyFirstSubmitDate': '2019-05-27', 'studyFirstSubmitQcDate': '2019-06-12', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of subtherapeutic antiinfective concentrations', 'timeFrame': 'four years', 'description': 'Number of subtherapeutic concentrations from different antiinfectives in critically ill patients'}, {'measure': 'Correlation of meropenem concentration in serum to the concentration in brain fluid', 'timeFrame': 'during the treatment with an external ventricular drainage', 'description': 'The concentration of meropenem in the brain fluid of 30 patients with an external ventricular drainage will be correlated to their serum concentration'}, {'measure': 'Subtherapeutic antiinfective concentrations during hemoadsorption', 'timeFrame': 'during hemoadsorption treatment', 'description': 'Subtherapeutic concentrations of antiinfectives in serum during hemoadsorption treatment'}], 'secondaryOutcomes': [{'measure': '28-day mortality of patients with therapeutic drug monitoring of antiinfectives', 'timeFrame': 'during intensive care treatment', 'description': 'Correlation of antiinfective concentrations in serum to 28-day mortality'}, {'measure': 'ICU-free days of patients with therapeutic drug monitoring of antiinfectives', 'timeFrame': 'during intensive care treatment', 'description': 'Correlation of antiinfective concentrations in serum to ICU-free days to day 28'}, {'measure': 'Sofa-score course of patients with therapeutic drug monitoring of antiinfectives', 'timeFrame': 'during the treatment with the antiinfectives', 'description': 'Correlation of antiinfective concentrations in serum to sofa-score'}, {'measure': 'Time course of Interleukin-6 in patients with therapeutic drug monitoring of antiinfectives', 'timeFrame': 'during the treatment with the antiinfectives', 'description': 'Correlation of antiinfective concentrations to Interleukin-6 in critically ill patients'}, {'measure': 'Time course of CRP in patients with therapeutic drug monitoring of antiinfectives', 'timeFrame': 'during the treatment with the antiinfectives', 'description': 'Correlation of antiinfective concentrations to CRP in critically ill patients'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TDM', 'Routine', 'intensive care patients'], 'conditions': ['Infection, Bacterial']}, 'referencesModule': {'references': [{'pmid': '40279026', 'type': 'DERIVED', 'citation': 'Weber F, Scharf C, Aulin LBS, Weinelt F, Paal M, Mikus G, Vogeser M, Habler K, Huisinga W, Zoller M, Michelet R, Kloft C, Liebchen U. Model-informed identification of optimised dosing strategies for meropenem in critically ill patients receiving SLEDD: an observational study. Infection. 2025 Oct;53(5):1819-1831. doi: 10.1007/s15010-025-02504-0. Epub 2025 Apr 25.'}, {'pmid': '35599248', 'type': 'DERIVED', 'citation': 'Scharf C, Weinelt F, Schroeder I, Paal M, Weigand M, Zoller M, Irlbeck M, Kloft C, Briegel J, Liebchen U. Does the cytokine adsorber CytoSorb(R) reduce vancomycin exposure in critically ill patients with sepsis or septic shock? a prospective observational study. Ann Intensive Care. 2022 May 23;12(1):44. doi: 10.1186/s13613-022-01017-5.'}, {'pmid': '33292582', 'type': 'DERIVED', 'citation': 'Scharf C, Liebchen U, Paal M, Taubert M, Vogeser M, Irlbeck M, Zoller M, Schroeder I. The higher the better? Defining the optimal beta-lactam target for critically ill patients to reach infection resolution and improve outcome. J Intensive Care. 2020 Nov 23;8(1):86. doi: 10.1186/s40560-020-00504-w.'}]}, 'descriptionModule': {'briefSummary': 'Therapeutic drug monitoring of antiinfectives in intensive care patients is an usual research topic of the last years. Based on research result, which have shown subtherapeutic plasma concentrations of antibiotics, a routines therapeutic drug monitoring for β-lactam-antibiotics was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany. This study is an prospective evaluation of these TDM-program.', 'detailedDescription': 'Bacterial infections are associated with high mortality in intensive care patients. Antibiotic therapy is the only causal opportunity to treat those infections. Pharmacokinetic and -dynamic changes in critically ill patients lead to unpredictable plasma concentrations of the applied drugs. Research results of the last years with many quantified plasma concentrations in subtherapeutic levels yield to the recommendation of the Paul-Ehrlich-Society for an routines therapeutic drug monitoring of antibiotics in intensive care patients. These was implemented in January 2018 at Clinic for Anesthesiology at University Hospital, LMU Munich, Germany for all intensive care patients as a routines procedure. The introduced study is a prospective evaluation of the TDM-program with regard to improvement opportunity, influencing factors and parallels to other studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Critically ill intensive care patients who were included in the routines TDM-program since January 2018.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* routines TDM of antiinfectives\n\nExclusion Criteria:\n\n* TDM is not available'}, 'identificationModule': {'nctId': 'NCT03985605', 'acronym': 'TAPSI', 'briefTitle': 'Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness = TAPSI', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Therapeutic Drug Monitoring of Antiinfectives for Patients With Severe Illness', 'orgStudyIdInfo': {'id': 'LMU 18-578'}}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'Department of Anaesthesiology of the University Hospital of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Bruegel Mathias, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Laboratory Medicine of the University Hospital of Munich'}, {'name': 'Liebchen Uwe, Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology of the University Hospital of Munich'}, {'name': 'Ines Schroeder, Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology of the University Hospital of Munich'}, {'name': 'Paal Michael, Dr.rer.nat.', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Laboratory Medicine of the University Hospital of Munich'}, {'name': 'Bernhard Zwissler, Prof.Dr.med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anaesthesiology of the University Hospital of Munich'}, {'name': 'Daniel Teupser, Prof.Dr.med.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Laboratory Medicine of the University Hospital of Munich'}, {'name': 'Lesca Holdt, Prof.Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Laboratory Medicine of the University Hospital of Munich'}, {'name': 'Michael Vogeser, Prof.Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Laboratory Medicine of the University Hospital of Munich'}, {'name': 'Eike Speck', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology of the University Hospital of Munich'}, {'name': 'Michael Irlbeck, PD.Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology of the University Hospital of Munich'}, {'name': 'Thomas Weig, PD.Dr.med.', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Anaesthesiology of the University Hospital of Munich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'sharing individual participant data is restricted by EU General Data Protection Regulation (GDPR)'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Zoller MD', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}