Status:
COMPLETED
Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Pleural Infection
Empyema
Eligibility:
All Genders
18+ years
Phase:
NA
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 evac...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04350502
Start Date
July 18 2019
End Date
December 1 2025
Last Update
December 8 2025
Active Locations (1)
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1
CHU Amiens
Amiens, France, 80480