ebulising Amoxicillin-Clavulanic Acid in Patients with COPD (NACAP)

Phase 2

Withdrawn

Conditions: 10024970
COPD

Registration Number: NL-OMON36305

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

• A clinical diagnosis of COPD, as defined by GOLD criteria,
• Admitted with signs and symptoms of an exacerbation of COPD, defined as an acute negative change from the baseline, reported by the patient, in dyspnoea and/or sputum volume and/or colour of sputum (yellowish or greenish sputum) and/or cough
• Age 40 years or over
• Current or former smoker.

Exclusion Criteria

• Impaired renal function (GFR < 30)
• Current pneumonia, defined as an acute respiratory tract illness associated with radiographic shadowing on a chest radiograph which was neither pre-existing nor of any other cause.
• Allergy for penicillin, amoxicillin or clavulanic acid
• Respiratory insuffiency and hypercapnia measured by arterial blood gas analyses

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary: At day 3 sputum samples will be collected and the amoxicillin<br /><br>concentration will be determined in order to obtain a number (percentage) of<br /><br>patients that adhere to an amoxicillin sputum level higher than the MIC90.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary:<br /><br>• To investigate whether nebulisation of amoxicillin clavulanic acid results in<br /><br>a decrease of hospitalisation days of patients with an exacerbation of COPD<br /><br>compared to the ASPECT study.<br /><br>• To investigate the tolerability of nebulised amoxicillin clavulanic acid.<br /><br>• To obtain information on distribution and systemic exposure of amoxicillin<br /><br>when nebulised.</p><br>