Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49528
Enrollment
20
Registered
2020-05-01
Start date
2020-06-17
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

pleural effusion Pus in the area between the lungs

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 pH1000 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

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.

Design outcomes

Primary

MeasureTime frame
Endpoints are the probability of target attainment in pleural fluid of intravenous amoxicillin(-clavulanic acid).

Secondary

MeasureTime frame
The secondary endpoint is 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)