No registrations found.
ID
Source
Brief title
Health condition
AECOPD (Acute exacerbation of COPD)
inhalation
nebulization
antibiotics
amoxicillin
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid by adverse effects monitoring.
Background summary
N/A
Study objective
Not applicable: kinetic study to investigate sputum amoxicillin levels (time > MIC) during 3 consecutive days of inhaling amoxicillin clavulanic acid b.i.d.
Study design
Nebulizations will take place for 3 days while hospitalized. Nebulization will take place two times a day. Every day the patient will fill in a short questionnaire evaluating the tolerability of the nebulization. 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).
Intervention
The included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose. (for 3 days)
Department of Pulmonology<br>
PO Box 50.000
P.D.L.P.M. Valk, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872610
P.vanderValk@mst.nl
Department of Pulmonology<br>
PO Box 50.000
P.D.L.P.M. Valk, van der
Enschede 7500 KA
The Netherlands
+31 (0)53 4872610
P.vanderValk@mst.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5712 |
| NTR-old | NTR5865 |
| Other | : ABR55935 |