Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Drug Monitoring of Antibiotics in Critical Care Patients (DRAK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date January 24, 2013
First Posted Date February 15, 2013
Last Update Posted Date March 31, 2015
Study Start Date March 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2013)
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.
Original Primary Outcome Measures
 (submitted: February 13, 2013)
Variability of antibiotic serum concentrations in critically ill patients [ Time Frame: 1 Year ]
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.
Change History Complete list of historical versions of study NCT01793012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 2, 2013)
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.
Original Secondary Outcome Measures
 (submitted: February 13, 2013)
correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters [ Time Frame: 1 Year ]
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.
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Monitoring of Antibiotics in Critical Care Patients
Official Title Drug Monitoring of Antibiotics in Critical Care Patients
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.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hospitalisation in the critical care unit of the Department of Anaesthesiology of the University Hospital of Munich
Condition
  • ARDS
  • Sepsis
Intervention Not Provided
Study Groups/Cohorts critically ill intensive care patients
Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 13, 2013)
6
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01793012
Other Study ID Numbers MUC 428-12
DRKS00004426 ( Other Identifier: German clinical trials register )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Zoller MD, Ludwig-Maximilians - University of Munich
Study Sponsor Ludwig-Maximilians - University of Munich
Collaborators Not Provided
Investigators
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
PRS Account Ludwig-Maximilians - University of Munich
Verification Date March 2015