NCT01793012|Completed
Drug Monitoring of Antibiotics in Critical Care Patients
DRAK
Loading search results
DRAK
Sponsor study identifier
Secondary identifiers
OTHER · German clinical trials register
observational
186
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Infections are critical factors for the survival of critically ill patients. A broad, high-dose and early initial therapy of antibiotics is of particular relevance. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 24, 2013
Actual (reported)February 15, 2013
Actual (reported)March 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)Variability of antibiotic serum concentrations in critically ill patients
The primary goal of this study is to evaluate the variability of antibiotic serum concentrations in critically ill patients. In total, serum concentrations of 6 different antibiotics (piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, and colistin) in 100-200 patients of the ICU will be determined by liquid chromatography mass spectrometry.
2 Years
correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters
2 Years
Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Department of Anaesthesiology of the University Hospital of Munich
Munich, 81377, Germany
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.
Bernhard Zwissler, Prof.Dr.med.
Department of Anaesthesiology of the University Hospital of Munich
Daniel Teupser, Prof.Dr.med.
Institute of Laboratory Medicine of the University Hospital of Munich
Johannes Zander, Dr. med.
Institute of Laboratory Medicine of the University Hospital of Munich
Michael Zoller, Dr. med.
Department of Anaesthesiology of the University Hospital of Munich
186 participants (actual enrollment reported by the registry).
First Submitted
January 24, 2013
First Posted
February 15, 2013
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Immune Activation, Hypoxia and Vasoreaction in Sepsis of Pulmonary Versus Abdominal Origin
Contact the study team to confirm eligibility.
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.
Lorenz Frey, Dr. med.
Department of Anaesthesiology of the University Hospital of Munich
Michael Vogeser, Prof.Dr.med.
Institute of Laboratory Medicine of the University Hospital of Munich
Mathias Bruegel, Dr. med.
Institute of Laboratory Medicine of the University Hospital of Munich
Lesca Holdt, Dr.rer.nat.
Institute of Laboratory Medicine of the University Hospital of Munich
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
September 2, 2020
Record last verified: 2020-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: