Community-acquired Pneumonia Clinical Trial
— PK-plèvreOfficial title:
Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections
Verified date | September 2023 |
Source | Centre Hospitalier Universitaire, Amiens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
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 |
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