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Drug Monitoring of Antibiotics in Critical Care Patients (DRAK)

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ClinicalTrials.gov Identifier: NCT01793012
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Michael Zoller MD, Ludwig-Maximilians - University of Munich

Brief Summary:

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.


Condition or disease
ARDS Sepsis

Detailed Description:
Substantial variations of serum concentrations of different antibiotics with partly insufficient levels have been observed in critically ill patients. The high variabilities between the pharmacokinetic parameters in different patients argue for a therapeutic drug monitoring (TDM) in intensive care units. TDM may lower the risk of overdosage with possible adverse and toxic effects as well as the risk of underdosage with possible insufficient therapeutic effects and development of antibiotic resistance. The aim of this study is to evaluate variabilities of pharmacokinetic parameters of different widely used antibiotics and to correlate them with clinical and laboratory parameters. Therefore, numerous clinical and laboratory parameters including serum, urine and dialysate concentrations of 6 different antibiotics will be determined in 100 - 200 critically ill patients of the Department of Anaesthesiology, University Hospital of Munich. Laboratory parameters (e.g. inflammatory parameters) will be quantified by facilities of the Institute of Laboratory Medicine, University Hospital of Munich. Concentrations of antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS). We expect that correlations between antibiotic serum concentrations and clinical and laboratory outcome parameters will be found.

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Study Type : Observational
Actual Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Monitoring of Antibiotics in Critical Care Patients
Study Start Date : March 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Group/Cohort
critically ill intensive care patients
Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin



Primary Outcome Measures :
  1. Variability of antibiotic serum concentrations in critically ill patients [ Time Frame: 2 Years ]
    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.


Secondary Outcome Measures :
  1. correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters [ Time Frame: 2 Years ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Criteria

Inclusion Criteria:

  1. Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
  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:

  1. Prophylactic antibiotics without clinical assessment for the presence of infection
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793012


Locations
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Germany
Department of Anaesthesiology of the University Hospital of Munich
Munich, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Investigators
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Study Director: Bernhard Zwissler, Prof.Dr.med. Department of Anaesthesiology of the University Hospital of Munich
Study Director: Daniel Teupser, Prof.Dr.med. Institute of Laboratory Medicine of the University Hospital of Munich
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: Michael Vogeser, Prof.Dr.med. Institute of Laboratory Medicine 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Zoller MD, senior physician, Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier: NCT01793012     History of Changes
Other Study ID Numbers: MUC 428-12
DRKS00004426 ( Other Identifier: German clinical trials register )
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015

Keywords provided by Michael Zoller MD, Ludwig-Maximilians - University of Munich:
therapeutic drug monitoring
antibiotics
inflammation parameters
critically ill patients
septicaemia
intensive care unit

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents