Cystic Fibrosis Clinical Trial
Official title:
Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy
This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.
AZLI, marketed as Cayston, is an inhaled beta-lactam antibiotic. It has a license for the
chronic suppression of Pseudomonas aeruginosa (PA). Current standard practice dictates the
use of two IV antipseudomonal antibiotics for the treatment of acute pulmonary exacerbations.
The increasing survival, and hence population, in CF means that newer antimicrobial
strategies are required in order to manage antimicrobial resistance, minimise adverse
systemic effects of heavy antimicrobial exposure and also make effective use of resources.
Inhaled antibiotics are commonly used in the chronic suppression of PA yet their use has not
been thoroughly investigated in acute pulmonary exacerbation. Inhaled antibiotics deliver
their drugs directly to the target-site with minimal systemic absorbance, making them an
attractive candidate for treatment of acute exacerbations.
Recently, it has become apparent that the bacterial community is much more complex than
initially thought. The microbiome, a term used to describe the polymicrobial community in the
lungs, has become apparent due to the use of modern culture-independent methods to detect
bacteria. The microbiome changes in composition and structure around the time of
exacerbations and in response to treatment, although these changes have not been
prospectively characterised.
We have designed an open-label randomised, controlled cross-over trial to investigate the
clinical effectiveness of of AZLI in the treatment of acute pulmonary exacerbation, whilst
simultaneously comparing the effect inhaled and intravenous antibiotics have on the
microbiome.
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