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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21366
Enrollment
8
Registered
2013-05-05
Start date
2013-05-01
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

Acute exacerbation of COPD

Interventions

The included patient will be given amoxicillin clavulanic acid by inhalation twice daily in a fixed dose.

Sponsors

Medisch Spectrum Twente
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 ward A4 or C4; 4. Able to produce sputum; 5. Age 40 years or over; 6. 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. (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 outcomes

Primary

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

Secondary

MeasureTime frame
Amoxicillin levels in sputum give information about the appropriateness of the given dose.

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)