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

L

Ludwig Maximilian University of Munich

Status

Completed

Conditions

Ventriculitis, Infectious

Study type

Observational

Funder types

Other

Identifiers

NCT04426383
LMU 20-169

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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