NCT03970265

Brief Summary

Infections are critical factors for the survival of critically ill patients. A serious problem is the high variability of antibiotic concentrations in critically ill patients. This may result in the risk of underdosage with possible ineffective therapeutic levels as well as in the risk of overdosage with possible adverse and toxic effects. Essential for the effectiveness of antibiotic therapy is the antibiotic concentration at target site. The goal of this study is to establish a method to extract Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) for antibiotic concentration measurements in patients following lung Transplantation and to calculate a tissue/serum concentration ratio. Improved knowledge regarding tissue penetration of Antibiotics may help to optimize drug dosing and management.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

September 2, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

May 27, 2019

Last Update Submit

September 1, 2020

Conditions

Lung Transplantation

Keywords

Interstitial lung fluidEpithelial lining fluidAntibiotic concentration in the lung

Outcome Measures

Primary Outcomes (1)

  • Meropenem concentration in Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) in 30 explanted lungs

    The primary goal of this study is to measure Meropenem concentration by LC-MS/MS in ELF and ILF from 30 explanted lung tissue.

    1 year

Secondary Outcomes (1)

  • Correlation of blood and tissue concentrations of Meropenem

    1 year

Interventions

extraction of ELF and ILF from explanted lung tissue; meropenem concentration in ELF and ILF; ELF on postoperative day 1-5 when bronchoscopy is performed within clinical routine.DIAGNOSTIC_TEST

Interventions will only be performed on explanted lung tissue ex vivo and on supernatant of bronchoscopy and are therefore non-invasive

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung transplant patients at University Hospital of Munich

You may qualify if:

  • Lung Transplantation at University Hospital of Munich
  • Administration of Meropenem as perioperative antibiotic prophylaxis

You may not qualify if:

  • missing informed consent
  • subsequent withdrawal of the participation in the study by the patient or the guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology of the University Hospital of Munich

Munich, 81377, Germany

Location

Related Publications (1)

  • Paal M, Scharf C, Denninger AK, Ilia L, Kloft C, Kneidinger N, Liebchen U, Michel S, Schneider C, Schropf S, Schuster C, Vogeser M, Weinelt F, Zander J, Zoller M, Schroeder I. Target Site Pharmacokinetics of Meropenem: Measurement in Human Explanted Lung Tissue by Bronchoalveolar Lavage, Microdialysis, and Homogenized Lung Tissue. Antimicrob Agents Chemother. 2021 Nov 17;65(12):e0156421. doi: 10.1128/AAC.01564-21. Epub 2021 Sep 27.

    PMID: 34570645DERIVED

Study Officials

  • Michael Zoller, Dr.med.

    Department of Anaesthesiology, University Hospital, LMU Munich

    PRINCIPAL INVESTIGATOR

  • Ines Schroeder, Dr.med.

    Department of Anaesthesiology, University Hospital, LMU Munich

    PRINCIPAL INVESTIGATOR

  • Mathias Brügel, Dr.med.

    Institute of Laboratory Medicine, University Hospital, LMU Munich

    PRINCIPAL INVESTIGATOR

  • Michael Vogeser, Prof.Dr.med.

    Institute of Laboratory Medicine, University Hospital, LMU Munich

    STUDY CHAIR

  • Christina Scharf, Dr.med.

    Department of Anaesthesiology, University Hospital, LMU Munich

    STUDY CHAIR

  • Uwe Liebchen, Dr.med.

    Department of Anaesthesiology, University Hospital, LMU Munich

    STUDY CHAIR

  • Eike Speck, Dr.med.

    Department of Anaesthesiology of the University Hospital of Munich

    STUDY CHAIR

  • Paal Michael, Dr.rer.nat.

    Institute of Laboratory Medicine of the University Hospital of Munich

    STUDY CHAIR

  • Alexander Indrich, Dr.med.

    Department of Anaesthesiology of the University Hospital of Munich

    STUDY CHAIR

  • Daniel Siegl, Dr.med.

    Department of Anaesthesiology of the University Hospital of Munich

    STUDY CHAIR

  • Bernhard Zwissler, Prof.Dr.med

    Department of Anaesthesiology of the University Hospital of Munich

    STUDY DIRECTOR

  • Daniel Teupser, Prof.Dr.med.

    Institute of Laboratory Medicine of the University Hospital of Munich

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2019

First Posted

May 31, 2019

Study Start

August 15, 2019

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

September 2, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)