Characterisation of macrophage and cytokine profiles in epithelial lining fluid (ELF) of patients with bacterial pneumonia

Characterisation of macrophage and cytokine profiles in epithelial lining fluid (ELF) of patients with bacterial pneumonia - MD-ELFI Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035879

Enrollment

Registered

2025-09-02

Start date

2026-04-27

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J15 J80

Interventions

Group 1: For this study, invasively ventilated patients with bacterial pneumonia are being recruited, who have an indication for empiric antibiotic therapy. Antibiotics are regularly used as part of t

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - mechanically ventilated patients with pneumonia and an indication for guideline- based antibiotic therapy, treated in one of the anesthesiologically managed intensive care units at the University Hospital Augsburg - written informed consent has been obtained (either from the patient themselves, from a proxy, or through a consultative physician procedure)

Exclusion criteria

Exclusion criteria: - active participation in a clinical trial according to the German Medicines Act (AMG) / Medical Device Regulation (MPDG) - women during pregnancy or breastfeeding - patients with pre-existing interstitial lung diseases

Design outcomes

Primary

Measure	Time frame
The minimum concentration of the measured antibiotic in the bronchoalveolar lavage (Cmin).	—

Secondary

Measure	Time frame
Pharmacokinetic/Pharmacodynamic Parameters/Indices: - Area under the concentration-time curve (AUC) in plasma and subcutaneous tissue - Maximum concentrations (Cmax) in plasma, interstitial fluid of subcutaneous tissue (ISF), and bronchoalveolar lavage (BAL) - Half-life (t1/2) in plasma and ISF - T > MIC (Time above Minimum Inhibitory Concentration) - AUC/MIC (Area under the curve to minimum inhibitory concentration ratio) - AUCtissue/AUCplasma ratio - AUCBAL/AUCplasma ratio Typification of the Immune Status (in plasma and BAL): - Determination of erythrocytes, thrombocytes, and leukocytes - Determination of M1 monocyte count and differentiation using surface antigens (CD14, CD16, CD32, CD64, CD80/86, HLA-DR) - Determination of M2 monocyte count and differentiation of membrane-bound and soluble surface antigens: CD14, sCD14, CD16, CD163, sCD163, CD206 - Measurement of biomarkers: IL-1ß, IL-6, TNF-a, IL-8, IL-12, IL-18, TGF-ß, IL-10, IL-1RA, IL-13 - Additionally in plasma: sTNF-R1 (soluble tumor necrosis factor receptor 1), bicarbonate, and protein C - Exosomes	—

Measure

Time frame

Pharmacokinetic/Pharmacodynamic Parameters/Indices: - Area under the concentration-time curve (AUC) in plasma and subcutaneous tissue - Maximum concentrations (Cmax) in plasma, interstitial fluid of subcutaneous tissue (ISF), and bronchoalveolar lavage (BAL) - Half-life (t1/2) in plasma and ISF - T > MIC (Time above Minimum Inhibitory Concentration) - AUC/MIC (Area under the curve to minimum inhibitory concentration ratio) - AUCtissue/AUCplasma ratio - AUCBAL/AUCplasma ratio Typification of the Immune Status (in plasma and BAL): - Determination of erythrocytes, thrombocytes, and leukocytes - Determination of M1 monocyte count and differentiation using surface antigens (CD14, CD16, CD32, CD64, CD80/86, HLA-DR) - Determination of M2 monocyte count and differentiation of membrane-bound and soluble surface antigens: CD14, sCD14, CD16, CD163, sCD163, CD206 - Measurement of biomarkers: IL-1ß, IL-6, TNF-a, IL-8, IL-12, IL-18, TGF-ß, IL-10, IL-1RA, IL-13 - Additionally in plasma: sTNF-R1 (soluble tumor necrosis factor receptor 1), bicarbonate, and protein C - Exosomes

—

Countries

Germany

Contacts

Public ContactPhilipp Simon

Universitätsklinikum Augsburg

philipp.simon3@uk-augsburg.de+49 821 162378

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026