Pharmacokinetic and pharmacodynamic target attainment of amoxicillin(-clavulanic acid) in pleural empyema fluid and complicated parapneumonic effusio

Recruiting

• Conditions: pleural effusion; Pus in the area between the lungs; 10004018

• Registration Number: NL-OMON49528
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Age >= 18 years
Diagnosed with pleural empyema or complicated parapneumonic effusion, based on
the criteria mentioned below, and in need of pleural fluid drainage.
o presence of pus or positive Gram*s stain or culture from the pleural fluid.
o pleural pH<7.2 or pleural fluid glucose value <2.2 mmol/l or pleural fluid
LDH value >1000 IU/L
Receiving IV amoxicillin 1000mg 4 times daily or amoxicillin-clavulanic acid
1000/200mg 4 times daily; dosage if necessary adapted to renal function
Able and willing to give informed consent (or consent by family member or legal
representative)

Exclusion Criteria

Critically ill patients admitted to the ICU, or patients of the general ward
who became critically ill and got transferred to the ICU during the duration of
the study.
Pre-existing ipsilateral pleural effusion or other cause of pleural effusion
(e.g. cancer) more likely.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Endpoints are the probability of target attainment in pleural fluid of<br /><br>intravenous amoxicillin(-clavulanic acid). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint is the penetration ratio of the antibiotics from blood<br /><br>plasma to pleural fluid, expressed as the fAUC0-6/8 of pleural fluid divided by<br /><br>the fAUC0-6/8 of plasma. </p><br>