Antimicrobial resistance is a significant challenge facing global healthcare. The unnecessary use of antibiotics is a key driver in the development of antibiotic resistance. Cystic Fibrosis (CF) represents a unique disease model to study bacterial resistance and to explore therapeutic strategies for same, as chronic lung infection overlaps with acute lung exacerbation's caused by a multitude of organisms. With time, chronic polymicrobial infection develops, with the most dominant infecting organism being Pseudomonas aeruginosa. In acute CF infections, empiric intravenous antibiotics are usually given for two weeks. Recurrent infections and treatments result in increasing antimicrobial resistance, and alterations in pathogen host interactions in the lung and gut flora. Next-generation DNA sequencing technology now offers DNA-based personalised diagnostics and treatment strategies. Enhancing our knowledge of the microbiome allows the use of stratified targeted antibacterial therapy that can be compared with standard empirical antibacterial therapy currently used. Cystic Fibrosis Microbiome-determined Antimicrobial Therapy Trial in Exacerbations: Results Stratified (CFMATTERS) will provide a randomized multi-centre controlled trial of microbiome-derived antimicrobial treatments versus current empirical therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
223
University College Cork
Cork, Cork, Ireland
The percentage change in recovery (post-exacerbation) FEV1 relative to the previous pre-exacerbation FEV1.
Time frame: Time from enrollment to 14 days post initiation of IV antibiotics for elligible exacerbation.
The time to next pulmonary exacerbation
Time frame: Time from pulmonary exacerbation day 0, to next pulmonary exacerbation up to study close month 21
The improvement in symptom burden by day 7 as determined by Cystic Fibrosis Respiratory Symptom Diary (CFRSD)
As determined by Cystic Fibrosis Respiratory Symptom Diary (CFRSD)
Time frame: Time from pulmonary exacerbation day 0 to day 7 of pulmonary exacerbation
The improvement in health related quality of life at day 28 post treatment and at 3 months as determined by the Cystic Fibrosis Questionnaire Revised (CFQR)
As determined by the Cystic Fibrosis Questionnaire Revised (CFQR)
Time frame: Time from pulmonary exacerbation day 0 to day 28 and month 3 post study treatment
Total number of i.v. antibiotic days (home or in hospital) from time of randomisation in the trial
Time frame: Time from enrollment in the study up to study close month 21
Change in FEV1
Time frame: Time from enrollment in the study up to study close month 21
Total number of exacerbations post trial treatment
Time frame: Time from pulmonary exacerbation day 0 to study close month 21
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