CFMATTERS Study
Research type
Research Study
Full title
Cystic Fibrosis Microbiome determined Antimicrobial Therapy Trial in Exacerbations: Results Stratified
IRAS ID
148496
Contact name
Stephen Liggett
Contact email
Clinicaltrials.gov Identifier
Project reference: 603038, EC Cordis database
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Patients with Cystic Fibrosis (CF) experience chronic pulmonary infection which leads to progressive respiratory deterioration, punctuated by acute episodes of worsened respiratory symptoms (increased cough and sputum, decreased lung function). These episodes are named “Pulmonary exacerbations”.
When CF sputum is analysed with conventional microbiology methods (culture), Pseudomonas aeruginosa is the most frequent bacteria identified. However, novel sensitive next generation technologies show that more than 60 different bacteria are present in CF sputum . All these bacteria together represent the “CF lung microbiome”.
Standard treatment of pulmonary exacerbations involves the use of two intravenous antibiotics, usually Ceftazidime and Tobramycin, for 14 days. This strategy targets P. aeruginosa but not the other bacteria in the CF lung microbiome.
CFMATTERS is a multi-centre study proposing “microbiome-directed” therapy for exacerbations which combines Ceftazidime and Tobramycin with a third antibiotic. This combination will target P. aeruginosa and the two other most abundant bacteria identified in the sputum microbiome.
Adult patients with P. aeruginosa infection will be recruited, when stable, from CF clinics at the Belfast Health and Social Care Trust. After informed consent is obtained, approximately 40 patients will be enrolled and equally randomised between the control (empiric treatment) and intervention arm (microbiome-directed). At this time point, their sputum will be analysed by microbiome analysis. Whenever they have an exacerbation, they will receive predetermined antibiotics (specific to their treatment arm). We will then record and compare the clinical effectiveness of both strategies looking at lung function tests and clinical information. All study visits will occur during routine outpatient appointments or hospitalisation.
It is hoped that “microbiome-directed” therapy will be a more effective means of treating the bacteria causing exacerbations and as a consequence, antibiotic use will decrease and patients will preserve better lung function.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
15/WM/0005
Date of REC Opinion
18 Feb 2015
REC opinion
Further Information Favourable Opinion