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8 Recent Developments in C. difficile Infection
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Clostridium difficile infection has frequently been the topic of breaking news on Healio.com over the past month.
Seres’ oral microbiome therapeutic SER-109 failed to meet the primary endpoint in its clinical trial, while the FDA delayed its approval decision for Merck’s bezlotoxumab, and fast-tracked development of Morphochem’s novel intravenous candidate.
Moreover, new research from Mayo Clinic investigators showed a link between C. difficile infection and post-infectious irritable bowel syndrome, and showed that gut microbiome markers can predict treatment response and recurrent infection.
Here, we present a recap of the 8 most popular recent articles on C. difficile infection presented by Healio Gastroenterology.
Seres’ microbiome drug fails to reduce C. difficile recurrence risk
Seres Therapeutics’ announced interim results from the phase 2 ECOSPOR trial of its investigational oral microbiome-based therapeutic SER-109, which failed to meet the primary endpoint of reducing the relative risk for recurrent C. difficile infection at up to 8 weeks.
“These are unexpected clinical results in view of the positive data in our prior investigator-sponsored phase 1b trial, as well as in a wide range of supporting clinical and preclinical data,” Roger Pomerantz, MD, president, CEO and chairman of Seres, said in a press release. Read more
FDA delays approval decision for Merck’s bezlotoxumab
The FDA extended the Prescription Drug User Fee Act goal date for Merck’s investigational biologic for the prevention of recurrent C. difficile infection, bezlotoxumab, by 3 months, according to a press release from the manufacturer. The new PDUFA goal date is October 23.
“Essentially, the FDA has concerns with the efficacy analyses in the MODIFY I and MODIFY II studies,” Colleen R. Kelly, MD, of the Lifespan Women’s Medicine Collaborative, Alpert Medical School of Brown University, told Healio Gastroenterology. Read more
FDA issues QIDP, Fast Track designations to novel IV antibacterial for C. difficile infection
The FDA has granted Qualified Infectious Disease Product and Fast Track designations to MCB3837, Morphochem’s novel intravenous antibacterial candidate for treating C. difficile infection, the manufacturer announced.
“MCB3837 is a water-soluble injectable small-molecule prodrug of the active substance MCB3681,” which may selectively target C. difficile pathogens based on its strong pharmacodynamics effects, narrow Gram-positive spectrum and favorable effects on commensal flora, according to a press release. Read more
Guest Commentary: Preventing and treating recurrent C. difficile infections
In this guest commentary, Ciaran Kelly, MD, discusses treatment and prevention of recurrent C. difficile infections following presentations on the topic delivered at the inaugural ASM Microbe 2016 meeting. Read more
AGA receives NIH funding for first national FMT registry
The National Institute of Allergy and Infectious Diseases of the NIH has provided funding to launch the AGA Fecal Microbiota Transplantation National Registry, the first national registry to track short- and long-term outcomes in patients who have undergone the gut-microbiome based therapy.
“AGA is eager to put a formal infrastructure into place for physicians and patients to report information that will standardize best practices for FMT, while offering insight into the gut microbiome and its role in human health and disease," AGA President Timothy C. Wang, MD, AGAF, said in a press release. Read more
New-onset IBS common after C. difficile infection
Patients with C. difficile infection have a high risk for developing post-infectious irritable bowel syndrome, particularly those with longer duration of C. difficile infection, anxiety and higher BMI, according to a recent study published in Alimentary Pharmacology and Therapeutics.
“Clinicians should consider the possibility of PI-IBS while assessing patients with ongoing symptoms after CDI, and further research is needed to determine pathophysiological mechanisms of PI-IBS following CDI,” Madhusudan Grover, MBBS, from the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn., told Healio Gastroenterology. Read more
Microbiome markers predict C. difficile treatment response, recurrence
Markers of specific alterations in the gut microbiota appeared predictive of response to C. difficile treatment and recurrent infection in a recent study.
“In this study, ... we identified microbiome markers at the time of initial diagnosis that can predict response to therapy in patients with C. difficile infection,” Purna C. Kashyap, MBBS, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn., told Healio Gastroenterology. Read more
Age, presence of toxin B antibodies influence C. difficile recurrence
A recent analysis suggests C. difficile infection patients aged at least 65 years are at greater risk of recurrence, while those with serum anti-toxin B antibodies appear to be protected from additional episodes.
According to Oliver A. Cornely, MD, FACP, and Maria J.G.T. Vehreschild, DrMed, both of the University Hospital of Cologne, these findings could help guide precision treatments for CDI and recurrence, but highlight the growing need for a validated and commercially available antibody diagnostic. Read more