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

NCT04350502 | Completed

• 1 other identifier: PI2019_843_0002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pleural Infection; Empyema; Community-acquired Pneumonia; Pharmacokinetic; Amoxicillin

Keywords

Pleural Infection; Empyema; Community-acquired Pneumonia; pharmacokinetic; amoxicillin; clavulanic acid; pneumococcal antigen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

complicated pleural infection patients

EXPERIMENTAL

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

Procedure: chest tube drainage; Biological: antibiotic concentration in pleural fluid; Drug: Amoxicillin + clavulanic acid

Interventions

chest tube drainage PROCEDURE

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).

complicated pleural infection patients

antibiotic concentration in pleural fluid BIOLOGICAL

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

complicated pleural infection patients

Amoxicillin + clavulanic acid DRUG

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

complicated pleural infection patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Empyema; Community-Acquired Pneumonia

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Damien BASILLE, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 17, 2020
• Study Start: July 18, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)