Drug Monitoring of Antibiotics in Critical Care Patients
NCT ID: NCT01793012
Last Updated: 2020-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
186 participants
OBSERVATIONAL
2013-03-31
2015-01-31
Brief Summary
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A serious problem is the high variability of antibiotic serum concentrations after administration of antibiotics in patients of the critical care units. This may result in the risk of underdosage with possible ineffective therapeutic levels as well as in the risk of overdosage with possible adverse and toxic effects. The goal of this study is to determine antibiotic concentrations in blood and to evaluate concentrations with the course of the therapy. The measurement of antibiotic concentrations in blood may allow an individual adaption of the dose in future.
100 - 200 patients will be included in this study. Only critically ill patients of the ICU of the Department of Anaesthesiology will be included that receive one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and colistin.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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critically ill intensive care patients
Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Presence of infection by clinical assessment
3. Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
4. Bolus administration of selected antibiotics
5. Valid informed consent subscribed by the patient or by his or her legal guardian or - if only a provisional guardian is defined - by the provisional guardian.
Exclusion Criteria
2. Planned shorter hospital stay than 4 days
3. Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
4. Only a single dose of an antibiotic per day
5. Subsequent withdrawal of the participation in the study by the patient or the guardian
18 Years
ALL
No
Sponsors
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Ludwig-Maximilians - University of Munich
OTHER
Responsible Party
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Michael Zoller MD
senior physician
Principal Investigators
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Bernhard Zwissler, Prof.Dr.med.
Role: STUDY_DIRECTOR
Department of Anaesthesiology of the University Hospital of Munich
Daniel Teupser, Prof.Dr.med.
Role: STUDY_DIRECTOR
Institute of Laboratory Medicine of the University Hospital of Munich
Johannes Zander, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Institute of Laboratory Medicine of the University Hospital of Munich
Michael Zoller, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesiology of the University Hospital of Munich
Lorenz Frey, Dr. med.
Role: STUDY_CHAIR
Department of Anaesthesiology of the University Hospital of Munich
Michael Vogeser, Prof.Dr.med.
Role: STUDY_CHAIR
Institute of Laboratory Medicine of the University Hospital of Munich
Mathias Bruegel, Dr. med.
Role: STUDY_CHAIR
Institute of Laboratory Medicine of the University Hospital of Munich
Lesca Holdt, Dr.rer.nat.
Role: STUDY_CHAIR
Institute of Laboratory Medicine of the University Hospital of Munich
Locations
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Department of Anaesthesiology of the University Hospital of Munich
Munich, , Germany
Countries
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References
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Bilal M, Zoller M, Fuhr U, Jaehde U, Ullah S, Liebchen U, Busker S, Zander J, Babouee Flury B, Taubert M. Cefepime Population Pharmacokinetics, Antibacterial Target Attainment, and Estimated Probability of Neurotoxicity in Critically Ill Patients. Antimicrob Agents Chemother. 2023 Jul 18;67(7):e0030923. doi: 10.1128/aac.00309-23. Epub 2023 Jun 27.
Ehmann L, Zoller M, Minichmayr IK, Scharf C, Maier B, Schmitt MV, Hartung N, Huisinga W, Vogeser M, Frey L, Zander J, Kloft C. Role of renal function in risk assessment of target non-attainment after standard dosing of meropenem in critically ill patients: a prospective observational study. Crit Care. 2017 Oct 21;21(1):263. doi: 10.1186/s13054-017-1829-4.
Taubert M, Zoller M, Maier B, Frechen S, Scharf C, Holdt LM, Frey L, Vogeser M, Fuhr U, Zander J. Predictors of Inadequate Linezolid Concentrations after Standard Dosing in Critically Ill Patients. Antimicrob Agents Chemother. 2016 Aug 22;60(9):5254-61. doi: 10.1128/AAC.00356-16. Print 2016 Sep.
Zander J, Dobbeler G, Nagel D, Maier B, Scharf C, Huseyn-Zada M, Jung J, Frey L, Vogeser M, Zoller M. Piperacillin concentration in relation to therapeutic range in critically ill patients--a prospective observational study. Crit Care. 2016 Apr 4;20:79. doi: 10.1186/s13054-016-1255-z.
Zoller M, Maier B, Hornuss C, Neugebauer C, Dobbeler G, Nagel D, Holdt LM, Bruegel M, Weig T, Grabein B, Frey L, Teupser D, Vogeser M, Zander J. Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study. Crit Care. 2014 Jul 10;18(4):R148. doi: 10.1186/cc13984.
Other Identifiers
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DRKS00004426
Identifier Type: OTHER
Identifier Source: secondary_id
MUC 428-12
Identifier Type: -
Identifier Source: org_study_id
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