Pharmacokinetic of Amoxicillin and Clavulanacid in pneumonic, interstitial lung tissue measured by in vivo microdialysis, in patients with pleural empyema treated by decortication.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003107-36-AT

Enrollment

Unknown

Registered

2005-11-04

Start date

2005-10-21

Completion date

Unknown

Last updated

2016-10-31

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

Conditions

To measure the time versus concentration profile of Amoxicillin and Clavulanacid in the interstitial space of infected lung tissue as the target site of infection following intravenous administration of Amoxicillin and Clavulanacid

Interventions

Trade Name: Augmentin iv. 2,2 g Tockensubstanz zur Inf.bereitung Product Name: Amoxicillin, Clavulanacid Pharmaceutical Form: Intravenous infusion Other descriptive name: Amoxicillin Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with thoracic empyema treated by decortication and stable hemodynamic conditions, after informed consent will be included. Patients with pre-existent known drug allergy will be excluded. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy against study medication, Pregnancy, Coagulopathies, positive HIV-serology, positive Hepatitis-serology, Cortisol-medication, renal insufficiency.

Design outcomes

Primary

Measure	Time frame
Main Objective: Amoxicillin and Clavulanacid have been shown as sufficient treatment in case of severe pleural empyema in the perioperative phase of the disease. Nevertheless, remnant thick pleural membranes at the mediastinum as well as pneumonic infiltration lead sometimes to recurrence of empyema. One of the reasons of recurrence may be that concentration of antibiotics at the target site, the infected lung and pleural membranes are not high enough to neutralize the pathogens. By applying a pharmacokinetic approach based on the measurement of free interstitial concentrations by microdialysis, the efficiency of these antibiotics to eradicate bacteria at the relevant target site will be tested in our study. This will lead to a better understanding for antibiotic potential in infected lung tissue and pleural membranes and may result in a rational dosing regimen. ;Secondary Objective: To measure the time versus concentration profile of Amoxicillin and Clavulanacid in serum, interstitial space of infected lung tissue and pleural membranes, following administration of Amoxicillin 2g and Clavulanacid 200 mg (2,2 g intravenous).;Primary end point(s): To measure the time versus concentration profile of Amoxicillin and Clavulanacid in the interstitial space of infected lung tissue as the target site of infection following intravenous administration of Amoxicillin and Clavulanacid	—

Measure

Time frame

Main Objective: Amoxicillin and Clavulanacid have been shown as sufficient treatment in case of severe pleural empyema in the perioperative phase of the disease. Nevertheless, remnant thick pleural membranes at the mediastinum as well as pneumonic infiltration lead sometimes to recurrence of empyema. One of the reasons of recurrence may be that concentration of antibiotics at the target site, the infected lung and pleural membranes are not high enough to neutralize the pathogens. By applying a pharmacokinetic approach based on the measurement of free interstitial concentrations by microdialysis, the efficiency of these antibiotics to eradicate bacteria at the relevant target site will be tested in our study. This will lead to a better understanding for antibiotic potential in infected lung tissue and pleural membranes and may result in a rational dosing regimen. ;Secondary Objective: To measure the time versus concentration profile of Amoxicillin and Clavulanacid in serum, interstitial space of infected lung tissue and pleural membranes, following administration of Amoxicillin 2g and Clavulanacid 200 mg (2,2 g intravenous).;Primary end point(s): To measure the time versus concentration profile of Amoxicillin and Clavulanacid in the interstitial space of infected lung tissue as the target site of infection following intravenous administration of Amoxicillin and Clavulanacid

—

Countries

Austria

Outcome results

None listed

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