Amoxicillin-clavulanic acid Levels in Sputum After Nebulization in AECOPD (ALSAN)
Phase 2
- Conditions
- COPD1000401810024970
- Registration Number
- NL-OMON53015
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
Not available
- 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
3) Admitted to the ward of pulmonary medicine
4) Age 40 years or over
5) Current or former smoker
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Dose exposure data as determined by sputum concentrations of amoxicillin.<br /><br>Amoxicillin levels in sputum give information on the appropriateness of the<br /><br>dose given from a calculated time > MIC.<br /><br>To obtain top, mid and trough sputum levels of amoxicillin between two doses,<br /><br>patients are asked to give up sputum after inhalation(top), at one point during<br /><br>the day(mid) and before the next inhalation (trough).</p><br>
- Secondary Outcome Measures
Name Time Method <p>A short questionnaire is given to the patient intended to give insight in the<br /><br>subjective perception of side effects after nebulization (tolerability).</p><br>