CFMATTERS

Frequently Asked Questions about CFMATTERS

What is CFMATTERS about?

CFMATTERS (Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified) is a research study of Microbiome-directed antibiotics in patients with Cystic Fibrosis (CF) exacerbations: results stratified. Cystic Fibrosis is a chronic, progressive, genetic disease that primarily affects the lungs, gastrointestinal, pancreas and reproductive systems.

 

The antibiotic prescribed to each patient is decided on a number of different factors, but it is unclear as to how best to decide which specific antibiotics are best suited to individual patients. Most people with CF are given the same antibiotics or same combinations of antibiotics each time they have a lung infection.

 

We have developed a new method of deciding what antibiotics should be given to patients based on examining the sputum (phlegm) of each individual patient with CF and tailoring the antibiotic choice to your individual’s needs, using new DNA based technologies as opposed to traditional culture methods. We believe this will reduce overall antibiotic usage, and optimize dosage and duration strategies, as the therapy will be tailored to the actual individual patient needs and, consequently, decrease adverse effects as well as emergence of drug resistance. The throughput and quality of this next-generation DNA sequencing technology now brings DNA-based personalized diagnostics within immediate reach for routine application in medical diagnostics and treatment strategies.

 

 

 

What is involved in the project?

Consenting CF Patients will be enrolled to this research study when stable, and will then be randomized to the next eligible pulmonary exacerbation treated by either an initial empiric antibiotic regime as happens in current clinical practice or by an initial “tailored” antibiotic regimen. Tailored therapy will be based on the results of a recent sputum microbiome analysis that identifies in detail the bacteria that have chronically colonized the lungs of a given patient. The microbiome results, assigned intervention and the recommended antibiotics will remain unknown to the patient, clinician and all research staff until the participant subsequently presents with an acute exacerbation that meets specified eligibility criteria.

 

Approximately 252 patients with CF will be enrolled at 7 CFMATTERS Partner sites. The duration of this study will be approximately 36months.

 

The advent of new DNA based techniques provides exciting new opportunities to enhance our knowledge of the lung bacteria. Based on this profiling of sputum, the use of our targeted antibacterial therapy can be compared with a standard antibacterial therapy currently used. We believe this will reduce antibiotic usage, and optimize dosage and duration strategies, as the therapy will be tailored to the actual individual patient needs and, consequently, decrease adverse effects as well as emergence of drug resistance.

 

 

How can patients benefit from the results of CFMATTERS?

This new developed method of deciding what antibiotics should be given to patients based on examining the sputum (phlegm) of each individual patient with CF and tailoring the antibiotic choice to your individual’s needs, using new DNA based technologies as opposed to traditional culture methods, we believe this will reduce overall antibiotic usage, and optimize dosage and duration strategies, as the therapy will be tailored to the actual individual patient needs and, consequently, decrease adverse effects as well as emergence of drug resistance.

 

Recent scientific studies show a benefit using stratified, next-generation approach to antibacterial treatment in a disease model of chronic bacterial infection with super-imposed acute exacerbations.

 

The findings from this CF study are likely to be generalizable to other patient populations.  Current understanding of CF infection and treatment revolves around the concept of chronic infection with acute exacerbations. Similar clinical scenarios can be seen in recurrent urinary tract infections, burns, diabetic wounds and prostheses.

 

The advent of new DNA based techniques provides exciting new opportunities to enhance our knowledge of the lung bacteria. Based on this profiling of sputum, the use of our targeted antibacterial therapy can be compared with a standard antibacterial therapy currently used. We believe this will reduce antibiotic usage, and optimize dosage and duration strategies, as the therapy will be tailored to the actual individual patient needs and, consequently, decrease adverse effects as well as emergence of drug resistance.

 

Your cystic fibrosis may improve from this new microbiome antibiotic therapy. Your participation in the study may be helping patients in the future by giving important information about the microbiome antibiotic therapy in the treatment of CF.

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