Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal Fluid (EMIL)

Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal

Therapeutic drug monitoring of antibiotics in critically ill patients is a present research topic of the last ten years. Research results have shown subtherapeutic blood concentrations in those patients. However, the amount of antibiotics in the cerebrospinal fluid (CSF) in patients with ventriculitis or meningitis is still unclear. This study is a prospective study to evaluate the concentration of different antibiotics in the CSF in patients with an external ventricular drainage compared to antibiotic blood concentration.

Study Overview

• Status: Completed
• Conditions: Ventriculitis, Infectious

Detailed Description

Bacterial infections are still associated with a high mortality in intensive care unit patients. Especially patients diagnosed with ventriculitis caused by a bacterial infection have a bad outcome. Therefore, antibiotic therapy is the only causal opportunity to treat those infections. However, there are many chances in pharmacokinetic and -dynamic in critically ill patients with unpredictable antibiotic concentrations. Furthermore, it is important that the concentration in the blood as well as in the effect-compartment "CSF" is sufficient. Less data of the last years describe antibiotic concentrations in the CSF and show subtherapeutic levels, which is endangering for the therapeutic success. The introduced study is a prospective, observational study that analyses antibiotic concentrations in CSF in critically ill patients. The distribution between CSF and blood will be evaluated by comparing these two compartments.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 81377
    • Department of Anaesthesiology of the University Hospital of Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

critically ill patients with an external ventricular drainage and the need of antibiotic therapy

Description

Inclusion Criteria:

• written approval of the legal guardian
• external ventricular drainage
• antibiotic therapy

Exclusion Criteria:

• no approval
• no antibiotic therapy or no external ventricular drainage

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid	Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis	through study completion, on average 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-day mortality	evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid	through study completion, on average 2 years
Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein	Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the C-reactive protein in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of C-reactive protein	through study completion, on average 2 years
Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6	Correlation of different antibiotic concentrations in patients´ blood and cerebrospinal fluid and the interleucin 6 in the blood. Question of interest is, if therapeutic antibiotic concentration leads to a faster decrease of interleucin 6	through study completion, on average 2 years

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: Freie Universität Berlin
• Investigators: Principal Investigator: Michael Zoller, Ludwig-Maximilians - University of Munich

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: critically ill patients; cerebrospinal fluid; therapeutic drug monitoring (TDM)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Viral Diseases; Central Nervous System Infections; Encephalitis; Cerebral Ventriculitis
• Other Study ID Numbers: LMU 20-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No