No registrations found.
ID
Source
Brief title
Health condition
Pleural empyema, complicated parapneumonic effusion
Sponsors and support
Intervention
Outcome measures
Primary outcome
The probability of target attainment in pleural fluid of intravenous amoxicillin(-clavulanic acid)
Secondary outcome
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.
Background summary
Rationale: Pleural empyema has a high morbidity and mortality rate, for which timely and adequate treatment is of paramount importance. Unfortunately, to date the optimal antibiotic treatment in terms of dose, duration and route of administration is still subject of debate. Pleural empyema and complicated parapneumonic effusions are treated with prolonged intravenous antibiotic treatment. However, the evidence for and specifications of these recommendations are lacking, leading to inconsistent treatment policies between practitioners and possibly unnecessary patient exposure to the risks of prolonged parenteral antibiotics and prolonged hospitalization. As a prerequisite for recommendations regarding the dose, duration and route of administration, we should first establish whether the current recommended antibiotic agents achieve adequate drug levels at the site of infection to effectively kill the pathogen, by investigating whether the pharmacokinetic and pharmacodynamic target is attained in pleural effusion/empyema.
Objective: To determine the exposure of IV amoxicillin(-clavulanic acid) in pleural empyema fluid or complicated parapneumonic effusion and to assess the probability of PK/PD target attainment in the pleural fluid of patients diagnosed with pleural empyema or complicated parapneumonic effusion, with the currently recommended dosing regimens for the most commonly isolated pathogens
Study design: Prospective, observational study.
Study population: Hospitalized non-critically ill patients diagnosed with pleural empyema or complicated parapneumonic effusion, who are treated with antibiotics and chest tube drainage, with or without flushing.
Intervention: A maximum of 8 blood plasma samples and 12 pleural fluid samples will be collected.
Main study parameters/endpoints: Endpoints are the probability of target attainment in pleural fluid of intravenous amoxicillin(-clavulanic acid) and 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.
Study objective
To determine the exposure of IV amoxicillin(-clavulanic acid) in pleural empyema fluid or complicated parapneumonic effusion and to assess the probability of PK/PD target attainment in the pleural fluid of patients diagnosed with pleural empyema or complicated parapneumonic effusion, with the currently recommended dosing regimens for the most commonly isolated pathogens
Study design
Patients will have one or two study visits, depending on
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8378 |
| Other | METC AMC : Pending |