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

NCT04426383 | Completed

• 1 other identifier: LMU 20-169
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventriculitis, Infectious

Keywords

therapeutic drug monitoring (TDM); critically ill patients; cerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 28-day mortality

  through study completion, on average 2 years

• Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein

  through study completion, on average 2 years

• Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6

  through study completion, on average 2 years

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• Freie Universität Berlin: collaborator

Study Sites (1)

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

Location

Related Publications (2)

• Wicha SG, Kinast C, Munchow M, Wittova S, Greppmair S, Kunzelmann AK, Zoller M, Paal M, Vogeser M, Habler K, Weig T, Terpolilli N, Heck S, Dimitriadis K, Scharf C, Liebchen U. Meropenem pharmacokinetics in cerebrospinal fluid: comparing intermittent and continuous infusion strategies in critically ill patients-a prospective cohort study. Antimicrob Agents Chemother. 2024 Sep 4;68(9):e0045124. doi: 10.1128/aac.00451-24. Epub 2024 Jul 31.

  PMID: 39082803 DERIVED

• Chen Z, Taubert M, Chen C, Dokos C, Fuhr U, Weig T, Zoller M, Heck S, Dimitriadis K, Terpolilli N, Kinast C, Scharf C, Lier C, Dorn C, Liebchen U. Plasma and Cerebrospinal Fluid Population Pharmacokinetics of Vancomycin in Patients with External Ventricular Drain. Antimicrob Agents Chemother. 2023 Jun 15;67(6):e0024123. doi: 10.1128/aac.00241-23. Epub 2023 May 10.

  PMID: 37162349 DERIVED

MeSH Terms

Conditions

Cerebral Ventriculitis

Condition Hierarchy (Ancestors)

Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Study Officials

• Michael Zoller

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician, Department of Anaesthesiology, university hospital munich

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2020
• Primary Completion: January 31, 2022
• Study Completion: May 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)