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

• Conditions: Pleural empyema, complicated parapneumonic effusion

• Registration Number: NL-OMON24554
• Lead Sponsor: ot applicable.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• 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.
opresence of pus or positive Gram’s stain or culture from the pleural fluid.
opleural 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 non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The probability of target attainment in pleural fluid of intravenous amoxicillin(-clavulanic acid)

Secondary Outcome Measures

Name	Time	Method
The penetration ratio of the antibiotics from blood plasma to pleural fluid, expressed as the fAUC0-6/8 of pleural fluid divided by the fAUC0-6/8 of plasma.