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Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections (PK-plèvre)

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ClinicalTrials.gov Identifier: NCT04350502
Recruitment Status : Recruiting
First Posted : April 17, 2020
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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).


Condition or disease Intervention/treatment Phase
Pleural Infection Empyema Community-acquired Pneumonia Pharmacokinetic Amoxicillin Procedure: chest tube drainage Biological: antibiotic concentration in pleural fluid Drug: Amoxicillin + clavulanic acid Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections
Actual Study Start Date : April 4, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: complicated pleural infection patients
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
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




Primary Outcome Measures :
  1. Area Under the Pleural Concentration Versus Time Curve (AUC) of "amoxicillin and clavulanic acid" [ Time Frame: up to 72 hours after starting chest pleural drainage ]
    Area Under the Pleural Concentration Versus Time Curve (AUC) of "amoxicillin and clavulanic acid" in patients with a complicated pleural infection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04350502


Contacts
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Contact: Damien BASILLE, MD (33)322455910 basille.damien@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80480
Contact: Damien Basille, MD    (33)3-22-45-59-10    basille.damien@chu-amiens.fr   
Sub-Investigator: Youssef BENNIS, MD         
Sub-Investigator: Raphaël GUIHENEUF, MD         
Sub-Investigator: Jean Philippe LANOIX, MD         
Sub-Investigator: Claire ANDREJAK, Pr         
Sub-Investigator: Vincent JOUNIEAUX, Pr         
Sub-Investigator: Jean-Luc SCHMIT, Pr         
Sub-Investigator: Marion DESQUIENS, MD         
Sub-Investigator: Marc-Antoine MARCHAND, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Damien BASILLE, MD CHU Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04350502    
Other Study ID Numbers: PI2019_843_0002
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Pleural Infection
Empyema
Community-acquired Pneumonia
pharmacokinetic
amoxicillin
clavulanic acid
pneumococcal antigen
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Pneumonia
Empyema
Disease Attributes
Pathologic Processes
Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases
Suppuration
Inflammation
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors