Antibiotic penetration into the pleural space in patients with pleural empyema

Not Applicable

• Conditions: J86.9; J86; Pyothorax without fistula; Pyothorax

• Registration Number: DRKS00034732
• Lead Sponsor: niversitätsklinikum Augsburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time-curve from 0 to 8hours after application of antibiotic therapy

Secondary Outcome Measures

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