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

• Conditions: Acute exacerbation of COPD

• Registration Number: NL-OMON21366
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1. A clinical diagnosis of COPD, as defined by GOLD criteria;

2. Hospitalized for an acute exacerbation of COPD;

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);

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of inhalation of nebulized amoxicillin clavulanic acid, as determined by spirometry and adverse effects monitoring.

Secondary Outcome Measures

Name	Time	Method
Amoxicillin levels in sputum give information about the appropriateness of the given dose.