Not applicable: kinetic study to investigate sputum amoxicillin levels (time > MIC) during 3 consecutive days of inhaling amoxicillin clavulanic acid b.i.d.
ID
Bron
Verkorte titel
Aandoening
AECOPD (Acute exacerbation of COPD)
inhalation
nebulization
antibiotics
amoxicillin
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Not applicable: kinetic study to investigate sputum amoxicillin levels (time > MIC) during 3 consecutive days of inhaling amoxicillin clavulanic acid b.i.d.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
The included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose. (for 3 days)
Publiek
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
Wetenschappelijk
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
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5712 |
| NTR-old | NTR5865 |
| Ander register | : ABR55935 |