- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793012
Drug Monitoring of Antibiotics in Critical Care Patients (DRAK)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Munich, Germany, 81377
- Department of Anaesthesiology of the University Hospital of Munich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
- Presence of infection by clinical assessment
- Treatment of the patients with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
- Bolus administration of selected antibiotics
- 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:
- Prophylactic antibiotics without clinical assessment for the presence of infection
- Planned shorter hospital stay than 4 days
- Administration of the selected antibiotic 14 days to 48 hours before the begin of the study
- Only a single dose of an antibiotic per day
- Subsequent withdrawal of the participation in the study by the patient or the guardian
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Variability of antibiotic serum concentrations in critically ill patients
Time Frame: 2 Years
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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.
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2 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters
Time Frame: 2 Years
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Moreover, we will evaluate if antibiotic serum concentrations differ between the different diseases (e.g. ARDS, sepsis) and the different therapies (e.g. different transplantation types (liver,lung) patients with and without renal replacement therapy). Correlation between antibiotics serum concentrations and Apache II score / SOFA score. Correlation between antibiotics serum concentrations and CRP, procalcitonin, interleukin-6. Finally minimal inhibitory concentrations (MIC) of antibiotics will be documented in case of detection of pathogens. |
2 Years
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Collaborators and Investigators
Investigators
- Principal Investigator: Johannes Zander, Dr. med., Institute of Laboratory Medicine of the University Hospital of Munich
- Principal Investigator: Michael Zoller, Dr. med., Department of Anaesthesiology of the University Hospital of Munich
- Study Chair: Lorenz Frey, Dr. med., Department of Anaesthesiology of the University Hospital of Munich
- Study Chair: Mathias Bruegel, Dr. med., Institute of Laboratory Medicine of the University Hospital of Munich
- Study Chair: Lesca Holdt, Dr.rer.nat., Institute of Laboratory Medicine of the University Hospital of Munich
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MUC 428-12
- DRKS00004426 (OTHER: German clinical trials register)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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