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Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.


- candidate number14851
- NTR NumberNTR3983
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-mei-2013
- Secondary IDsNL 44131 CCMO
- Public TitleSafety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
- Scientific TitleSafety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
- ACRONYMSTONAC 2
- hypothesisNot applicable: Phase II study --> Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Acute Exacerbations of COPD.
- Healt Condition(s) or Problem(s) studiedAcute exacerbation of COPD
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate1-mei-2014
- Target number of participants8
- InterventionsThe included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose.
- Primary outcomeThe safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.
- Secondary outcomeAmoxicillin levels in sputum give information about the appropriateness of the given dose.
- TimepointsNebulizations 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.D.L.P.M. Valk, van der
- CONTACT for SCIENTIFIC QUERIESDr. P.D.L.P.M. Valk, van der
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD5-mei-2013 - 14-mei-2013


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