COPD
Conditions
Interventions
The included patient will be given amoxicillin clavulanic acid by inhalation
twice daily in a concentration of 50/10 mg/ml amoxicillin clavulanic acid in
the first two days. The last day only one in
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) A clinical diagnosis of COPD, as defined by GOLD criteria 2) Hospitalized for an acute exacerbation of COPD 3) Admitted to the ward of pulmonary medicine 4) Age 40 years or over 5) Current or former smoker
Exclusion criteria
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. 3) Recently diagnosed or unresolved lung malignancy 4) amoxicillin or clavulanic acid therapy within 3 days prior to admission, During the trial the patient cannot be treated with systemic amoxicillin or amoxicillin clavulanic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. To obtain top, mid and trough sputum levels of amoxicillin between two doses, patients are asked to give up sputum after inhalation(top), at one point during the day(mid) and before the next inhalation (trough). | — |
Secondary
| Measure | Time frame |
|---|---|
| A short questionnaire is given to the patient intended to give insight in the subjective perception of side effects after nebulization (tolerability). | — |
Countries
Netherlands
Outcome results
None listed