Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.

Clinical Trial Description

The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in patients with cystic fibrosis has increased dramatically over the last decade. Epidemiologic evidence suggests that persistent infection with MRSA may result in an increased rate of decline in FEV1 and shortened survival. Treatment of MRSA is a top priority. Inhaled antibiotics offer the advantage of high concentrations of antibiotic at the site of infection (the airway) while minimizing systemic side effects. Vancomycin is a glycopeptide antibiotic that has activity against MRSA. Anecdotal and retrospective peer-reviewed studies have demonstrated that inhaled vancomycin is safe and potentially effective in patients with cystic fibrosis and MRSA airway infection. Data evaluating the pharmacokinetics of vancomycin in sputum are needed before pursuing treatment trials. ;

Study Design

Related Conditions & MeSH terms

Cystic Fibrosis
Fibrosis
Methicillin-resistant Staphylococcus Aureus
Respiratory Aspiration

Clinical Trial Details

NCT number	NCT01509339
Study type	Interventional
Source	Case Western Reserve University
Contact
Status	Withdrawn
Phase	Phase 1
Start date	January 2012
Completion date	December 23, 2021

View Details

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