Drug Monitoring of Antibiotics in Critical Care Patients

NCT01793012 | Completed

• 2 other identifiers: MUC 428-12DRKS00004426
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; Sepsis

Keywords

therapeutic drug monitoring; antibiotics; inflammation parameters; critically ill patients; septicaemia; intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• correlate these serum concentrations with clinical and laboratory outcome Correlate serum concentrations with clinical and laboratory outcome parameters

  2 Years

Study Arms (1)

critically ill intensive care patients

Treatment with one or more of the following antibiotics: piperacillin/tazobactam, cefepime, meropenem, ciprofloxacin, linezolid, colistin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

Location

Related Publications (5)

• 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.

  PMID: 37366614 DERIVED

• 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.

  PMID: 29058601 DERIVED

• 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.

  PMID: 27324768 DERIVED

• 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.

  PMID: 27039986 DERIVED

• 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.

  PMID: 25011656 DERIVED

MeSH Terms

Conditions

Sepsis; Toxemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: February 15, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

DE (1)