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

Ventriculitis, Infectious Clinical Trial

— EMIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426383
• Other study ID #: LMU 20-169
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 1, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Ventriculitis
• Ventriculitis, Infectious

Locations

Country	Name	City	State
Germany	Department of Anaesthesiology of the University Hospital of Munich	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	Freie Universität Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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