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NCT03970265 Clinical Trial

Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.

Lung Transplantation Clinical Trial

— ALF  

Official title:
Development of a Method to Extract Interstitial Lung Fluid and Epithelial Lining Fluid for Antibiotic Concentration Measurement in Explanted Lung Tissue (Feasibility Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03970265
Other study ID # LMU 18-928
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 15, 2019
Est. completion date July 15, 2020

Study information
Verified date September 2020
Source Ludwig-Maximilians - University of Munich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

Informed consent will be obtained prior to inclusion. 30 patients following lung Transplantation at the University Hospital of Munich will be included in this study. Intravenous Meropenem will be administered as perioperative antibiotic prophylaxis for lung transplantation. Interstitial Lung Fluid and Epithelial Lining Fluid will be extracted immediately after explantation of the lung from explanted lung tissue. Concentrations of antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS) in ILF and ELF. Serum samples will be collected according to our in clinical routine established therapeutic drug monitoring. Tissue/Serum concentration ratio will be calculated. ELF will be collected on postoperative day 1-5 when bronchoscopy is performed during clinical routine. Numerous clinical and laboratory parameters will be determined. The investigators expect that correlations between antibiotic target site and blood concentrations and clinical and laboratory parameters will be found.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Lung Transplantation at University Hospital of Munich

2. Administration of Meropenem as perioperative antibiotic prophylaxis

3. Valid informed consent subscribed by the patient prior to inclusion

Exclusion Criteria:

1. missing informed consent

2. subsequent withdrawal of the participation in the study by the patient or the guardian

Study Design

Related Conditions & MeSH terms

Intervention

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

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

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlation of blood and tissue concentrations of Meropenem Calculation of tissue/serum concentration ratio will be calculated 1 year
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