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

NCT04350502 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Principal Investigators

  • Damien BASILLE, MD · CHU Amiens

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2025-12-01
Completion
2025-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350502 on ClinicalTrials.gov