Ventriculitis, InfectiousEMILNCT04426383
Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal Fluid
An observational study of Ventriculitis, Infectious, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventriculitis, Infectious
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2020to 1 May 2022
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patients with an external ventricular drainage and the need of antibiotic therapy
Who may be able to join
- written approval of the legal guardian
- external ventricular drainage
- antibiotic therapy
Who cannot join
- no approval
- no antibiotic therapy or no external ventricular drainage
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anaesthesiology of the University Hospital of Munich
Munich, 81377
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventriculitis, Infectious
- Keywords
- therapeutic drug monitoring (TDM), critically ill patients, cerebrospinal fluid
- Medical subject headings
- Cerebral Ventriculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid
Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis
Measured: through study completion, on average 2 years
Secondary outcomes (3)
28-day mortality
evaluation of the 28-day mortality in patients with therapeutic and subtherapeutic antibiotic concentrations in cerebrospinal fluid
Measured: 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
Measured: 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
Measured: through study completion, on average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion31 Jan 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventriculitis, InfectiousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Freie Universität Berlin
- Responsible party
- Principal investigator, Michael Zoller MD, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Zoller, Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426383
- Sponsor's protocol ID
- LMU 20-169
- Acronym
- EMIL
- Status last verified
- May 2022
- First submitted
- 4 Jun 2020
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39082803Chen 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.
PubMed 37162349
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a TDM Program for Intensive Care Patients in the Cerebrospinal
- ClinicalTrials.gov ID
- NCT04426383
- Acronym / sponsor ID
- EMIL / LMU 20-169
- Conditions
- Ventriculitis, Infectious
- Keywords
- therapeutic drug monitoring (TDM), critically ill patients, cerebrospinal fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Freie Universität Berlin
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients with an external ventricular drainage and the need of antibiotic therapy
Key inclusion criteria (3 listed)
- written approval of the legal guardian
- external ventricular drainage
- antibiotic therapy
Key exclusion criteria (2 listed)
- no approval
- no antibiotic therapy or no external ventricular drainage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid
Time frame: through study completion, on average 2 years
Percentage of subtherapeutic concentrations of different antibiotics in different subgroups like ventriculitis vs. no ventriculitis
3 secondary outcomes
28-day mortality
Time frame: through study completion, on average 2 years
Correlation of antibiotic concentration in cerebrospinal fluid and C-reactive protein
Time frame: through study completion, on average 2 years
Correlation of antibiotic concentration in cerebrospinal fluid and interleucin 6
Time frame: through study completion, on average 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 39082803Wicha 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.
- Derived from this study: PubMed 37162349Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zoller principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventriculitis, Infectious, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of subtherapeutic antibiotic concentrations in cerebrospinal fluid (time frame: through study completion, on average 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04426383, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.