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…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints are the probability of target attainment in pleural fluid of
intravenous amoxicillin(-clavulanic acid).
Secondary outcome
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.
Background summary
Pleural empyema has a high morbidity and mortality rate and is therefore an
important clinical problem, 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 is treated with a prolonged intravenous antibiotic
treatment and current guidelines recommend to switch to oral therapy once the
patient has clinically improved. However, the evidence and specifications of
these recommendations are absent, 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
intravenous dosages of 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 empyema.
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 treated
with the currently recommended dosing regimens, for the most commonly isolated
pathogens
Study design
Prospective, observational study.
Study burden and risks
Patients will be treated as per standard patient care. The study will thus not
influence the treatment of the pleural empyema or complicated parapneumonic
effusion. Prolongation of the hospitalization or extra study visits won't be
necessary. hospital admission. Patients are exposed to extra peripheral blood
sample collection and pleural fluid collection, with a total of 4-8 and 6-12
samples respectively. To enhance patients comfort we will try to collect the
venous blood through an IV catheter. If this is not possible, this will be done
via direct venepuncture. The pleural fluid samples will be obtained through the
sampling port attached to the chest tube. These are both low-risk
interventions. Data obtained from our study will have impact on current
treatment strategies, which will be beneficial for future patients, science and
society.*
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
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 |
|---|---|
| CCMO | NL72499.018.20 |