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Amoxicillin-clavulanic acid Levels in Sputum After Nebulization


- candidate number24373
- NTR NumberNTR5865
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-mei-2016
- Secondary IDsABR55935 
- Public TitleAmoxicillin-clavulanic acid Levels in Sputum After Nebulization
- Scientific TitleAmoxicillin-clavulanic acid Levels in Sputum After Nebulization in AECOPD
- ACRONYMALSAN
- hypothesisNot applicable: kinetic study to investigate sputum amoxicillin levels (time > MIC) during 3 consecutive days of inhaling amoxicillin clavulanic acid b.i.d.
- Healt Condition(s) or Problem(s) studiedExacerbation, Acute exacerbation of COPD, COPD, Antibiotics, Amoxicillin
- Inclusion criteria1) 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 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.
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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2017
- Target number of participants21
- InterventionsThe included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose. (for 3 days)
- Primary outcomeDose 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 outcomeThe safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid by adverse effects monitoring.
- TimepointsNebulizations 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).
- Trial web sitenone
- 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)
- RECORD18-mei-2016 - 2-jul-2016


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