Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections

Community-acquired Pneumonia Clinical Trial

— PK-plèvre  

Official title:

Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04350502
• Other study ID #: PI2019_843_0002
• Status: Completed
• Phase: N/A
• Start date: April 4, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The incidence of pleural infection is increasing worldwide since the last two decades. Antibiotics are one of the cornerstones of the treatment of this disease and must be associated to a correct evacuation of the pleural effusion.

Data concerning the pleural diffusion of antibiotics currently used in community acquired pleural infection are scarce. The main objective of this study is to evaluate the pleural pharmacokinetic of amoxicillin and clavulanic acid in patients with a complicated pleural infection (patients who need a chest tube insertion).

Description:

Only scarce data are known on the pleural diffusion of antibiotics. Most of these data are concerning antibiotics that are not commonly used for the treatment of community-acquired pleural infections. Moreover, these data are obtained from studies using heterogenous methodologies (single or repeated evaluation of the antibiotic concentration in the pleural effusion, with or without correlation to the serum concentration; animal model or very specific population (i.e. uninfected patients or following lung surgery).

The main objective of this study is to evaluate the pleural pharmacokinetic of amoxicillin and clavulanic acid in patients with a community-acquired complicated pleural infection.

Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day). Repeated samples of pleural fluid and serum will be taken to evaluate antibiotics' concentrations at H0; H½; H1; H2; H3; H4; H8 and H24.

The follow-up and management of the included patients will not be modified by the study protocol except for the pleural and serum samples. Clinical, biological and radiological (chest x-ray and/or thoracic ultrasound) evaluation will be performed daily. Success of the pleural drainage will be assessed at day 3.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all adult patients (= 18 years old) hospitalized for a complicated community acquired pleural infection at University Hospital Amiens-Picardie.

• Complicated pleural infection is defined by the presence of one of the following criteria: frank pus, loculated pleural fluid, presence of organisms identified by Gram stain and/or culture from a non-purulent pleural fluid sample, pleural fluid pH <7.2, pleural fluid glucose <0.32g/l or large non-purulent effusion.

Exclusion Criteria:

• non-infectious pleural effusion

• hospital-acquired pleural infection

• patient treated with amoxicillin and clavulanic acid (if treatment was started more than > 24h ago)

• Minors, pregnant women, adult patients protected by law.

• Pleural infection requiring instant thoracic surgery

• allergy to beta-lactam

• Injection of contrast agent (Iomeron or Iohexol) during the 24 hours preceding or following the first dose of amoxicillin / clavulanic acid.

Related Conditions & MeSH terms

• Amoxicillin
• Communicable Diseases
• Community-acquired Pneumonia
• Empyema
• Infections
• Pharmacokinetic
• Pleural Infection
• Pneumonia

Intervention

Procedure:
• chest tube drainage
Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day).

Biological:
• antibiotic concentration in pleural fluid
Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day). Repeated samples of pleural fluid and serum will be taken to evaluate antibiotics' concentrations at H0; H½; H1; H2; H3; H4; H8 and H24

Drug:
• Amoxicillin + clavulanic acid
Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day). Repeated samples of pleural fluid and serum will be taken to evaluate antibiotics' concentrations at H0; H½; H1; H2; H3; H4; H8 and H24

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Pleural Concentration Versus Time Curve (AUC) of "amoxicillin and clavulanic acid"	Area Under the Pleural Concentration Versus Time Curve (AUC) of "amoxicillin and clavulanic acid" in patients with a complicated pleural infection	up to 72 hours after starting chest pleural drainage