Research into infections continues to be a top priority for the Cystic Fibrosis Foundation. Chronic infections and drug-resistant bacteria remain key challenges — even for those who take modulators, such as Trikafta.
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Research Into New Detection and Diagnostic Methods for Infections
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Infections in people with cystic fibrosis are usually diagnosed by culturing a sputum sample — mucus or phlegm coughed up from the lungs. It is difficult to obtain these samples from children and becoming increasingly difficult to get them from people with CF who are taking modulator therapies that help clear mucus from the lungs. Sputum cultures also can miss early signs of infection.
For these reasons, we are focused on developing new tests to detect and diagnose infections without using sputum — following up on promising work to use blood, urine, or breath to determine the presence of infections in the lung.
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In March we announced our investment of up to $2.3 million in Owlstone Medical to develop a test designed to detect Pseudomonas infections from a person’s breath. If successful, the test would allow care teams to identify new infections and monitor chronic infections in people with CF. This represents our first significant investment in detection technology.
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“Infections lead to lung damage, so it is incredibly important to detect and diagnose infections as quickly as possible and monitor changes,” said A. Whitney Brown, MD, vice president, clinical affairs, Cystic Fibrosis Foundation. “With less sputum to culture, we need to develop alternate tests that are not invasive and can deliver quick, accurate results.”
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Supporting academic researchers who are studying breath, blood, and urine as a potential way to identify infections in the lung
- Exploring industry programs to determine if urine may be an alternative specimen to identify Pseudomonas infections
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To enable these and other opportunities, we will be working with the Therapeutics Development Network (TDN) later this year to collect samples for Owlstone and other sponsors that are working on new ways to identify lung infections using specimens other than sputum. To facilitate sample collection, the TDN is developing a new study titled SEND-CF (Study to Enable New Diagnostics for Pulmonary Microbes in People with CF). The TDN, which is funded by the Foundation, is the largest cystic fibrosis clinical trials network in the world.
Look for more news on the development of these types of diagnostic tests in future emails.
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To combat the growing challenge of antibiotic resistance, we are advancing nontraditional ways to fight infections, including funding research into bacteriophage (phage) therapy.
Phage therapy is an experimental treatment in which specialized viruses are used to kill difficult-to-treat bacteria. Phages can be used to target specific hosts, such as certain strains of Pseudomonas and other disease-causing bacteria commonly found in the lungs of people with CF.
In February, we held a workshop to discuss what needs to be done to improve phage therapy research, including developing potential outcome measures for clinical trials, standardizing clinical trials, and overcoming barriers.
Here are some ongoing and upcoming phage studies that we are helping fund:
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BiomX is planning a Phase 2b trial to test a phage cocktail for the treatment of people with CF with chronic Pseudomonas.
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The POSTSTAMP trial has been selecting people with CF who have persistent nontuberculous mycobacteria (NTM) infections despite treatment. If their infection has at least one phage that is effective in killing it, they receive phage treatment for one year along with antibiotics. They will be compared to those who do not have a phage match and are being treated only with antibiotics.
- A Phase 1 pilot trial will test the safety and tolerability of a phage therapy cocktail targeting Achromobacter chronic infections. The goal is to collect enough data to move into a larger phage trial.
- A phage study is being planned to treat people with CF who have had three positive Burkholderia cepacia complex cultures in the last year.
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New Infection-Related Studies Enrolling |
Here are a few infection research studies that are enrolling:
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- The STOP 360 trial will compare the improvement of lung function and symptoms in those treated with one IV antibiotic versus one IV antibiotic plus IV tobramycin during an exacerbation.
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The STOP PEDS trial will evaluate the safety and effectiveness of two antibiotic treatment approaches for pulmonary exacerbations in children with CF. One treatment arm will receive immediate antibiotics treatment, while another will receive tailored treatment. A pilot study showed that 70% were able to prevent the use of oral antibiotics.
- To grow, bacteria rely on some processes that require iron. If gallium — an atom nearly identical to iron — is taken up by the bacteria instead, it can disrupt these processes and kill the bacteria. The ABATE trial will evaluate IV gallium in people with CF who have NTM infections.
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To find other infection-related studies, visit the Clinical Trial Finder. If you have questions about clinical trials, please contact the Clinical Trial Navigator — a designated person who provides one-on-one assistance for people with CF and their families.
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Stay connected with the CF Foundation via our social media channels or visit cff.org/news for the latest updates.
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4550 Montgomery Avenue, Suite 1100N | Bethesda, MD 20814 US
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