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Amoxicillin-clavulanic acid Levels in Sputum After Nebulization

Amoxicillin-clavulanic acid Levels in Sputum After Nebulization in AECOPD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28084
Enrollment
21
Registered
2016-05-18
Start date
2016-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AECOPD (Acute exacerbation of COPD) inhalation nebulization antibiotics amoxicillin

Interventions

The included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose. (for 3 days)

Sponsors

Medisch Spectrum Twente (Medical Center)
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid by adverse effects monitoring.

Contacts

Public ContactP.D.L.P.M. Valk, van der

Medisch Spectrum Twente Hospital Department of Pulmonology PO Box 50.000

P.vanderValk@mst.nl+31 (0)53 4872610

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)