Lung TransplantationALFNCT03970265
Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.
An observational study of Lung Transplantation, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- 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.
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2019to 15 Jul 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lung transplant patients at University Hospital of Munich
Who may be able to join
- Lung Transplantation at University Hospital of Munich
- Administration of Meropenem as perioperative antibiotic prophylaxis
- Valid informed consent subscribed by the patient prior to inclusion
Who cannot join
- missing informed consent
- subsequent withdrawal of the participation in the study by the patient or the guardian
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: Development of a Method to Extract Interstitial Lung Fluid and Epithelial Lining Fluid for Antibiotic Concentration Measurement in Explanted Lung Tissue (Feasibility Study)
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.
Read the detailed 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.
- Conditions
- Lung Transplantation
- Being tested
- 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.
- Keywords
- Interstitial lung fluid, Epithelial lining fluid, Antibiotic concentration in the lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Correlation of blood and tissue concentrations of Meropenem
Calculation of tissue/serum concentration ratio will be calculated
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start15 Aug 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Zoller MD, Ludwig-Maximilians - University of Munich
- Investigators
- Michael Zoller, Dr.med., Principal investigator, Department of Anaesthesiology, University Hospital, LMU MunichInes Schroeder, Dr.med., Principal investigator, Department of Anaesthesiology, University Hospital, LMU MunichMathias Brügel, Dr.med., Principal investigator, Institute of Laboratory Medicine, University Hospital, LMU MunichMichael Vogeser, Prof.Dr.med., Study chair, Institute of Laboratory Medicine, University Hospital, LMU MunichChristina Scharf, Dr.med., Study chair, Department of Anaesthesiology, University Hospital, LMU MunichUwe Liebchen, Dr.med., Study chair, Department of Anaesthesiology, University Hospital, LMU MunichEike Speck, Dr.med., Study chair, Department of Anaesthesiology of the University Hospital of MunichPaal Michael, Dr.rer.nat., Study chair, Institute of Laboratory Medicine of the University Hospital of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970265
- Sponsor's protocol ID
- LMU 18-928
- Acronym
- ALF
- Status last verified
- Sep 2020
- First submitted
- 27 May 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34570645
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03970265
- Acronym / sponsor ID
- ALF / LMU 18-928
- Conditions
- Lung Transplantation
- Keywords
- Interstitial lung fluid, Epithelial lining fluid, Antibiotic concentration in the lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 31 May 2019 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lung transplant patients at University Hospital of Munich
Key inclusion criteria (3 listed)
- Lung Transplantation at University Hospital of Munich
- Administration of Meropenem as perioperative antibiotic prophylaxis
- Valid informed consent subscribed by the patient prior to inclusion
Key exclusion criteria (2 listed)
- missing informed consent
- subsequent withdrawal of the participation in the study by the patient or the guardian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | – |
Primary outcome
Meropenem concentration in Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) in 30 explanted lungs
Time frame: 1 year
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 secondary outcome
Correlation of blood and tissue concentrations of Meropenem
Time frame: 1 year
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 2 Sep 2020.
- Derived from this study: PubMed 34570645Paal 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.
- Individual participant dataSharing planned: No
Related trials for Lung Transplantation
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RSV Vaccine in Transplant Recipients
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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, Dr.med. principal investigator
Department of Anaesthesiology, University Hospital, LMU Munich
Ines Schroeder, Dr.med. principal investigator
Department of Anaesthesiology, University Hospital, LMU Munich
Mathias Brügel, Dr.med. principal investigator
Institute of Laboratory Medicine, University Hospital, LMU 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 Lung Transplantation, 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 2 Sep 2020. 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?
Meropenem concentration in Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) in 30 explanted lungs (time frame: 1 year). 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 NCT03970265, which also lists 1 linked publication.
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 2 Sep 2020.