MedPath

Amoxicillin-clavulanic acid Levels in Sputum After Nebulizatio

Conditions
AECOPD (Acute exacerbation of COPD)inhalationnebulizationantibioticsamoxicillin
Registration Number
NL-OMON28084
Lead Sponsor
Medisch Spectrum Twente (Medical Center)
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
21
Inclusion Criteria

1) A clinical diagnosis of COPD, as defined by GOLD criteria

2) Hospitalized for an acute exacerbation of COPD

Exclusion Criteria

1) Current pneumonia, defined as an acute respiratory tract illness associated with radiographic shadowing on a X-ray or CT-scan of the chest which was neither pre-existing nor of any other cause.

2) Allergy for penicillin, amoxicillin or clavulanic acid.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Dose exposure data as determined by sputum concentrations of amoxicillin. Amoxicillin levels in sputum give information on the appropriateness of the dose given from a calculated time > MIC.
Secondary Outcome Measures
NameTimeMethod
The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid by adverse effects monitoring.
© Copyright 2025. All Rights Reserved by MedPath