No registrations found.
ID
Source
Brief title
Health condition
Acute exacerbation of COPD
Sponsors and support
Intervention
Outcome measures
Primary outcome
The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.
Secondary outcome
Amoxicillin levels in sputum give information about the appropriateness of the given dose.
Background summary
N/A
Study objective
Not applicable: Phase II study --> Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
Study design
Nebulizations will take place during hospitalization with a maximum of 7 days. Nebulization will take place two times a day. After every nebulization the patient will fill in a short questionnaire. Before and after the first nebulization spirometry will take place. Sputum will be collected before the second inhalation, at three times at day three and before the last inhalation. A blood sample will be taken at day 3.
Intervention
The included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose.
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 ward A4 or C4;
4. Able to produce sputum;
5. Age 40 years or over;
6. 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. (patients must have been treated with amoxicillin before without a report of allergic reactions);
3. History of severe AECOPD requiring mechanical ventilation;
4. Recently diagnosed or unresolved lung malignancy;
5. Impaired renal function (Creatinine Clearance < 20 ml/min);
6. Congestive Heart Failure (NYHA III-IV).
During the trial the patient cannot be treated with systemic 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 | NL3817 |
| NTR-old | NTR3983 |
| CCMO | NL44131.044.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |