COPD
Conditions
Interventions
Patients that are considered for treatment with amoxicillin clavulanic acid
will receive treatment by inhalation of 25/5 mg nebulised amoxicillin
clavulanic acid twice daily instead of oral or intra
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • A clinical diagnosis of COPD, as defined by GOLD criteria, • Admitted with signs and symptoms of an exacerbation of COPD, defined as an acute negative change from the baseline, reported by the patient, in dyspnoea and/or sputum volume and/or colour of sputum (yellowish or greenish sputum) and/or cough • Age 40 years or over • Current or former smoker.
Exclusion criteria
Exclusion criteria: • Impaired renal function (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: At day 3 sputum samples will be collected and the amoxicillin concentration will be determined in order to obtain a number (percentage) of patients that adhere to an amoxicillin sputum level higher than the MIC90. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: • To investigate whether nebulisation of amoxicillin clavulanic acid results in a decrease of hospitalisation days of patients with an exacerbation of COPD compared to the ASPECT study. • To investigate the tolerability of nebulised amoxicillin clavulanic acid. • To obtain information on distribution and systemic exposure of amoxicillin when nebulised. | — |
Countries
Netherlands
Outcome results
None listed