Antibiotic penetration into the pleural space in patients with pleural empyema

Antibiotic penetration into the pleural space in patients with pleural empyema - MD-Pleura

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034732

Enrollment

Registered

2024-07-19

Start date

2024-10-16

Completion date

Unknown

Last updated

2025-11-24

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

Conditions

J86.9 J86

Interventions

Group 1: Adult patients with pleural empyema of any origin, for whom antibiotic therapy and surgical evacuation of the pleural empyema via elective video-assisted thoracoscopy (VATS) or open thoracoto

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - written informed consent of the patient (given by the patient him/ herself, other methods of obtaining consent are not allowed)

Exclusion criteria

Exclusion criteria: - concurrent participation in other clinical trials according to the the German Medical Products Act (AMG) or the German Medical Devices Law (MPDG) - known allergies or hypersensitivity reactions to betalactams or any other antibiotics that are indicated for the therapy of pleural empyema according to local and national guidelines

Design outcomes

Primary

Measure	Time frame
Area under the concentration-time-curve from 0 to 8hours after application of antibiotic therapy	—

Secondary

Measure	Time frame
Further pharmacokinetic (PK) and pharmacodynamic (PD) parameters: - AUC0-8h in the costrodiaphragmal recessus (side of the pleural empyema), the subctaneous fatty tissue and the medistinal fatty tissue and in plasma - maximum concentrations (Cmax) - half lives (t1/2) PK/PD Indices: - T>MIC (time over MIC) - Cmax/MIC (MIC = minimal inhibitory concentration) - AUC/MIC in in plasma and dialysates - AUCtissue/AUCplasma ratio	—

Measure

Time frame

Further pharmacokinetic (PK) and pharmacodynamic (PD) parameters: - AUC0-8h in the costrodiaphragmal recessus (side of the pleural empyema), the subctaneous fatty tissue and the medistinal fatty tissue and in plasma - maximum concentrations (Cmax) - half lives (t1/2) PK/PD Indices: - T>MIC (time over MIC) - Cmax/MIC (MIC = minimal inhibitory concentration) - AUC/MIC in in plasma and dialysates - AUCtissue/AUCplasma ratio

—

Countries

Germany

Contacts

Public ContactPhilipp Simon

Universitätsklinikum Augsburg

philipp.simon3@uk-augsburg.de49 821 400 2378

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026