logo
#

Latest news with #Clostridioidesdifficile

Pseudomembranous Colitis (Clostridium Difficile Infection): Risks and Treatment Strategies
Pseudomembranous Colitis (Clostridium Difficile Infection): Risks and Treatment Strategies

Los Angeles Times

time22-05-2025

  • Health
  • Los Angeles Times

Pseudomembranous Colitis (Clostridium Difficile Infection): Risks and Treatment Strategies

Pseudomembranous colitis (PMC) is an antibiotic associated severe inflammatory condition of the colon caused by an overgrowth of Clostridium difficile (C. difficile), a toxin producing bacterium. It's known for forming yellow-white plaques – called pseudomembranes – on the lining of the colon which can be seen during colonoscopy or on histology [1], [6]. Although often linked to antibiotic use, PMC can present with a wide range of severity from mild diarrhea to life threatening colitis. While Clostridioides difficile (formerly Clostridium difficile) is the primary organism behind PMC, it's not the only one. Other pathogens have occasionally been found to cause similar colonic inflammation and pseudomembrane formation [1], [3]. But C. difficile is the most common and clinically relevant. The process starts with antibiotics. These medications while useful for treating bacterial infections can disrupt the balance of normal colonic flora in the gut. This gives C. difficile – often present in small amounts in the intestines – the opportunity to flourish [2], [7], [9]. Spores that were once dormant now find an environment ripe for growth. C. difficile produces two potent toxins, toxin A (TcdA) and toxin B (TcdB). These toxins bind to cells lining the colon, damaging them and setting off a cascade of inflammation. In severe cases the body's immune response and cell damage leads to the hallmark pseudomembranes seen in PMC [5]. Not all antibiotic therapy is created equal, but broad spectrum agents like clindamycin, cephalosporins and fluoroquinolones are often implicated. These drugs wipe out a wide range of gut flora making room for C. difficile to flourish [10]. PMC symptoms often start during or shortly after antibiotics: These symptoms can overlap with other conditions but the timing, especially after antibiotics, is a key clue. PMC doesn't affect everyone the same way. While some people have mild diarrhea others can spiral into severe colitis and complications like: These cases need urgent medical attention. Healthcare providers consider PMC when a patient on antibiotics develops sudden or worsening diarrhea, so rapid diagnosis is key. But diagnosing it isn't always easy. Metronidazole: Metronidazole is used for mild to moderate PMC. It's effective, cheap and oral [1], [8]. But it's being replaced by other treatments due to higher relapse rates and slower symptom resolution. Vancomycin: Oral vancomycin is now the go to for severe or complicated C. difficile infections. It stays in the gut (where it's needed) without being absorbed into the bloodstream so it targets the infection locally. PMC relapses so recurrent Clostridioides difficile infection is common. Some patients may need extended vancomycin tapers, fidaxomicin (a newer antibiotic) or even fecal microbiota transplantation (FMT). FMT involves restoring healthy gut bacteria by transplanting stool from a donor—a treatment that's showing promising results in recurrent Clostridioides difficile infection cases [4]. One of the best ways to prevent PMC is smart antibiotic prescribing. Avoiding unnecessary prescriptions especially broad spectrum antibiotics can help preserve the natural gut microbiome and prevent C. difficile overgrowth. Hospitals and healthcare facilities also have a role to play by enforcing infection control measures such as hand hygiene and isolation protocols to limit the spread of C. difficile spores. Pseudomembranous colitis is more than just a complication of antibiotic use—it's a serious gastrointestinal illness that needs timely diagnosis and treatment. Understanding the underlying disruption of gut microbiota and toxin production is key to managing and preventing this condition. As we learn more about PMC the emphasis remains on prevention through good antibiotic stewardship and early intervention when symptoms occur. [1] Surawicz, C. M., & McFarland, L. V. (1999). Pseudomembranous colitis: causes and cures. Digestion, 60(2), 91–100. [2] Janoir C. (2016). Virulence factors of Clostridium difficile and their role during infection. Anaerobe, 37, 13–24. [3] Tang, D. M., Urrunaga, N. H., & von Rosenvinge, E. C. (2016). Pseudomembranous colitis: Not always Clostridium difficile. Cleveland Clinic journal of medicine, 83(5), 361–366. [4] Surawicz, C. M., & McFarland, L. V. (2000). Pseudomembranous Colitis Caused by C. difficile. Current treatment options in gastroenterology, 3(3), 203–210. [5] Castagliuolo, I., & LaMont, J. T. (1999). Pathophysiology, diagnosis and treatment of Clostridium difficile infection. The Keio journal of medicine, 48(4), 169–174. [6] Farooq, P. D., Urrunaga, N. H., Tang, D. M., & von Rosenvinge, E. C. (2015). Pseudomembranous colitis. Disease-a-month : DM, 61(5), 181–206. [7] Trnka, Y. M., & Lamont, J. T. (1984). Clostridium difficile colitis. Advances in internal medicine, 29, 85–107. [8] Brar, H. S., & Surawicz, C. M. (2000). Pseudomembranous colitis: an update. Canadian journal of gastroenterology = Journal canadien de gastroenterologie, 14(1), 51–56. [9] Counihan, T. C., & Roberts, P. L. (1993). Pseudomembranous colitis. The Surgical clinics of North America, 73(5), 1063–1074. [10] Weymann L. H. (1982). Colitis caused by Clostridium difficile: a review. The American journal of medical technology, 48(11), 927–934.

Ferring Presents New Phase 3b Safety and Effectiveness Data for Recurrent
Ferring Presents New Phase 3b Safety and Effectiveness Data for Recurrent

Business Wire

time05-05-2025

  • Health
  • Business Wire

Ferring Presents New Phase 3b Safety and Effectiveness Data for Recurrent

PARSIPPANY, N.J.--(BUSINESS WIRE)--Ferring Pharmaceuticals presented initial findings from the investigational Phase 3b multi-center, single-arm CDI-SCOPE study evaluating the safety and effectiveness of REBYOTA ® (fecal microbiota, live – jslm) when administered by colonoscopy. REBYOTA is the first microbiome-based therapy approved for the prevention of recurrent Clostridioides difficile (C. diff) infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for C. diff infection. These data were presented at Digestive Disease Week 2025 (DDW2025) from May 3-6 in San Diego, CA. The single-arm CDI-SCOPE study demonstrated that treatment with REBYOTA administered by colonoscopy was safe. Only 5 treatment-emergent adverse events (TEAEs) – occurring in 9.8% (4/41) of participants – were considered possibly related to REBYOTA, all of which were mild in intensity and related to the gastrointestinal tract. Two participants withdrew consent and did not complete the 8-week follow-up assessment. "Colonoscopies are routinely used by physicians managing patients with recurrent C. difficile infection," said Dr. Paul Feuerstadt, M.D., F.A.C.G., A.G.A.F., Yale School of Medicine and PACT-Gastroenterology Center, a lead investigator of CDI-SCOPE. "The insights gained from this investigative study point to administration via colonoscopy as a promising potential option for physicians to consider for their patients." A second abstract from the CDI-SCOPE study reported the burden of rCDI on health-related quality of life (HRQoL) and any improvements after treatment among 73.2% (30/41) participants. Prior to REBYOTA treatment, the most experienced rCDI symptoms were diarrhea (100%, 30/30), abdominal pain (70.0%, 21/30), and fatigue or weakness (46.7%, 14/30). All participants (100%, 30/30) reported that CDI recurrence impacted their daily living, including disrupting their sleep and forcing them to be near a bathroom at all times. Most participants also said that rCDI affected their social life and relationships (96.7%, 29/30) and their emotional wellbeing (93.3%, 28/30). Following treatment with REBYOTA, 89.7% of participants (26/29) saw an improvement in their symptoms within the first month, and more than half (51.7%, 15/29) felt an improvement within the first week. Symptom severity rating scores (0-10, none to worst) decreased significantly at Week 8 for diarrhea (from 8.9 to 1.3), abdominal pain (from 7.5 to 1.6), and fatigue (from 8.1 to 1.7). 'Recurrent CDI is a life-altering condition that many patients in our CDI-SCOPE trial called 'a literal living nightmare' that makes it impossible to function,' said Raza Ahmed, MD, Senior Director of Medical Affairs, Ferring Pharmaceuticals. 'We are proud that REBYOTA has become an important, therapy for many patients who, for too long, were stuck in an agonizing cycle of CDI recurrence. With the data we are presenting this week at DDW, Ferring is continuing its commitment to supporting patients living with rCDI and their physicians by broadening the breadth of evidence.' A third CDI-SCOPE abstract showed that 90% of the physicians who completed the 41 colonoscopy procedures in the study had a 'positive' or 'very positive' experience across all aspects of administration, including the material preparation time and ease of passage through the colonoscope. One investigator reported their experience as 'somewhat negative' citing difficulty with connecting REBYOTA to the colonoscope. All 39 patients who completed 8-week visits were assessed by the physicians as either having 'much improved' or 'very much improved' on the clinical global impression – improvement scale (CGI-I). Additional Data from PUNCH™ Clinical Program Along with the data from CDI-SCOPE, Ferring also reported two analyses with data from the PUNCH™ clinical trial program. This included: Results from an integrated safety analysis of five clinical trials (n=1192) demonstrating a favorable safety profile with REBYOTA across all trials in the development program, including in participants with inflammatory bowel disease (IBD) and immunocompromising comorbidities. TEAEs were reported in 70.9% of patients who received REBYOTA, most of which were mild or moderate in severity and related to the gastrointestinal tract. Serious TEAEs were reported in 14.3% of patients receiving REBYOTA, most of which were related to rCDI and/or preexisting conditions, with few events (<1%) being considered possibly related to treatment. There was no clustering of serious TEAEs, including in comorbid subgroups. This new exploratory analysis of the PUNCH™ CD3 trial in which improvements in HRQoL were associated with changes in microbiome and metabolome composition. In a previous exploratory analysis, patients who responded to REBYOTA vs. placebo had a healthier gut microbiome composition with an increase in the relative abundance of beneficial gut microbiota (Bacteroidia and Clostridia) and a decrease in other bacteria (Gammaproteobacteria and Bacilli). This new analysis found that the greatest improvements in HRQoL – as measured using the disease-specific C. difficile Quality of Life Survey (Cdiff32), which examines physical, mental and social domains – were associated with the mental health domain, with the largest improvements associated with higher levels of Bacteroidia and Clostridia and lower levels of other bacteria. To learn more about REBYOTA and other information, please visit or About C. diff infection C. diff infection is a serious and potentially deadly infection that impacts people across the globe. The C. diff bacterium causes debilitating symptoms, such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea and colitis (an inflammation of the colon). 1 C. diff infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system. 2,3 It has been estimated that up to 35% of C. diff infection cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections. 4,5,6,7 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence. 6,7 Antibiotics – the current standard of care for treatment of C. diff infection – treat the disease but can also be a contributing factor to the cycle of recurrence. 1 About REBYOTA REBYOTA is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes – including Bacteroides. REBYOTA is delivered directly to the gut microbiome and is administered by a healthcare professional in one visit. INDICATION REBYOTA (fecal microbiota, live – jslm) is indicated for the prevention of recurrence of Clostridioides difficile (C. diff) infection in individuals 18 years of age and older, following antibiotic treatment for recurrent C. diff infection. Limitation of Use REBYOTA is not indicated for the treatment of C. diff infection. IMPORTANT SAFETY INFORMATION You should not receive REBYOTA if you have a history of a severe allergic reaction (e.g., anaphylaxis) to REBYOTA or any of its components. You should report to your doctor any infection you think you may have acquired after administration. REBYOTA may contain food allergens. Most common side effects may include stomach pain (8.9%), diarrhea (7.2%), bloating (3.9%), gas (3.3%), and nausea (3.3%). REBYOTA has not been studied in patients below 18 years of age. Clinical studies did not determine if adults 65 years of age and older responded differently than younger adults. You are encouraged to report negative side effects of prescription drugs to FDA. Visit or call 1-800-332-1088. Please click to see the full Prescribing Information. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately-owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. In the United States, Ferring is a leader in reproductive medicine, and in areas of gastroenterology and orthopaedics. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. The company was founded in 1950 and is headquartered in Saint-Prex, Switzerland. Ferring employs more than 7,000 people worldwide and markets its medicines in over 100 countries. Ferring USA is based in Parsippany, New Jersey, and employs more than 900 employees. For more information, please visit call 1-888-FERRING (1-888-337-7464), or connect with us on LinkedIn, and X. About DDW 2025 Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting from May 3-6, 2025. The meeting showcases more than 5,600 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at References: Centers for Disease Control and Prevention. What is C. diff? 7 Sep. 2022. Available at: Centers for Disease Control and Prevention. 2019 Antibiotic Resistance Threats Report: Clostridioides difficile. 23 Nov. 2021. Available at: Feuerstadt P, et al. Healthcare resource utilization and direct medical costs associated with index and recurrent Clostridioides difficile infection: a real-world data analysis. J Med Econ. 2020;23(6):603-609. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743. Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. 2021 Jul;27(7):828-838. doi: 10.18553/jmcp.2021.20395. Epub 2021 Mar 11. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18 (Suppl. 6): 21–27. Smits WK, et al. Clostridium difficile

Why Summit Therapeutics Inc. (SMMT) Soared Last Week
Why Summit Therapeutics Inc. (SMMT) Soared Last Week

Yahoo

time04-05-2025

  • Business
  • Yahoo

Why Summit Therapeutics Inc. (SMMT) Soared Last Week

We recently published a list of . In this article, we are going to take a look at where Summit Therapeutics Inc. (NASDAQ:SMMT) stands against other firms that soared last week. The past trading week saw a more calm, generally optimistic, market environment amid the temporary pause in tit-for-tat tariffs, buoyed further by a flurry of corporate earnings for the first quarter of the year. On a week-on-week basis, the tech-heavy Nasdaq rallied the most, up 3.4 percent, followed by the Dow Jones with 3 percent, and the S&P 500 by 2.9 percent. Beyond the major indices, 10 firms stood out, booking double-digit gains as high as 48 percent, thanks to better-than-expected earnings and outlook. In this article, we name this week's 10 best-performing mid-cap companies and detail the reasons behind their gains. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5-million trading volume. The stocks were chosen based on the highest percentage increase in closing prices on May 2 as against their prices a week earlier, or on April 25. A laboratory employee in a sterile environment inspecting a microscope focused on a Clostridioides difficile infection sample. Summit Therapeutics Inc. (NASDAQ:SMMT) Summit Therapeutics grew its share price by 18.88 percent last week to end Friday at $27.9 versus the $23.47 the week prior, as investor sentiment was boosted by an investment firm's bullish outlook despite the company's disappointing earnings performance in the first quarter of the year. In its market note, Cantor Fitzgerald reaffirmed its Overweight rating on Summit Therapeutics Inc. (NASDAQ:SMMT) stock, thanks to its promising ivonescimab bispecific antibody, which aims to cure cancer. Just recently, Summit Therapeutics Inc. (NASDAQ:SMMT) secured the green light from China to offer ivonescimab as a first-line treatment for PD-L1-positive NSCLC, paving the way for further expansion globally. 'We … appreciate the regulatory authorities for their efficient and diligent review, which enables us to offer this new treatment to patients in China,' the company said. In the first quarter, Summit Therapeutics Inc. (NASDAQ:SMMT) widened its net loss by 44.6 percent to $62.9 million from $43.5 million in the same period last year, as operating expenses picked up by 57.5 percent to $66.8 million from $42.4 million year-on-year. Overall, SMMT ranks 6th on our list of firms that soared last week. While we acknowledge the potential of SMMT as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than SMMT but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio

Warning over surge in terrifying bug that kills up to one in five people it infects - 'corridor care' in NHS hospitals is to blame
Warning over surge in terrifying bug that kills up to one in five people it infects - 'corridor care' in NHS hospitals is to blame

Daily Mail​

time01-05-2025

  • Health
  • Daily Mail​

Warning over surge in terrifying bug that kills up to one in five people it infects - 'corridor care' in NHS hospitals is to blame

Cases of a potentially killer infection that can spread rampantly in hospitals have surged by a third in a year, health officials have warned. Clostridioides difficile, commonly referred to as C. diff, is a highly contagious bacteria that causes diarrhoea. While mild for most people it can trigger life-threatening complications and kills up to one in five patients that fall ill with it. Now, in a report, the UK Health Security Agency (UKHSA), said the number of cases seen in 2023-24 was 29.5 per 100,000 people. This is a 33 per cent rise since 2020-21 and the highest level seen in over a decade, the body said. C. diff is considered to be the leading cause of healthcare-associated infections, those that happen when a patient is in hospital. The bug, which initially infects the bowel, is highly resistant to both heat and most disinfectant products. According to the new UKHSA report, the overwhelmed NHS could be to blame for the worrying surge. This UK Health Security Agency Chart shows the % increase in C. diff cases over time. Officials said not only were cases on the rise, the rate of the increase seemed to be accelerating The agency said corridor care — the practice of caring for patients in hallways amid a lack of available beds — could be leading to overwhelmed staff not following infection prevention control (IPC) methods. 'As corridor-care occurs when the system is under pressure, it is reasonable to assume difficulties with IPC compliance, not only due to stretched healthcare workers but also because, the tools for IPC, such as hand-wash basins, will not be as readily accessible in a non-clinical area,' they wrote. 'Further, cleaning standards for non-clinical areas (such as corridors) are less thorough than for clinical areas.' This, combined with the crowded nature of A&Es, could make such areas a potential source of C. diff infections. The agency added the role of corridor care in the rise of C. diff was currently the subject of research. Corridor care has now become so routine in parts of the NHS that some hospitals are now recruiting dedicated 'corridor medics' to staff these areas. And a damming report by the Royal College of Physicians earlier this year found four in five hospital medics had been forced to treat patients in 'unsuitable' public spaces. One doctor said a patient had died due to being positioned too far away from life-saving equipment. The latest NHS data, covering March, shows one in three A&E patients in England was forced to wait at least four hours to be seen. Estimates from the Royal College of Emergency Medicine suggest more than 1.5million patients were forced to wait 12 hours for care in 2023. UKHSA added that the massive increase in waiting lists for treatment post-Covid pandemic could also be contributing to the rise. As of the end of the last year the number of patients waiting for routine care in England was 7.5million. While this was a decrease from a peak of 7.7million in September 2023, it is still one-and-a-half times higher than in 2020. UKHSA said patients waiting for long periods for treatment are more likely to need antibiotics and this could be leaving them vulnerable to C. diff. Antibiotics can cause an imbalance in the bacteria that normally live in the bowel, increasing the risk of a C. diff infection. The bug becomes life threatening if the bacteria infect other parts of the body outside the bowel. This can trigger sepsis, a life-threatening over-reaction from the immune system to an infection. Another potential complication is the bacteria spilling into other areas of the abdomen causing a potentially deadly infection called peritonitis. The latest data from UKHSA showed fatality rates for C. diff were highest among the over 85s at nearly 20 per cent. Fatality rates decreased with age with patients between 45-to-64 years of age only have a 5 per cent chance of dying. 'Not only have rates [of increased year on year from 2020, but the rate of change over time is accelerating,' UKHSA wrote. The body added that while hospitals accounted for the greatest source of C. diff infections, cases had also increased seen in the community. C. diff is spread by spores in infected patients' faeces that can survive for an extremely long time in the environment. This allows them to be spread by people who have been in contact with infected patients or contaminated surfaces. Symptoms of a C. diff infection include diarrhoea, a high temperature, loss of appetite, nausea and stomach pain. People who have had diarrhoea and recently taken antibiotics, have any bloody diarrhoea or have had diarrhoea for a week or more should contact NHS 111 or their GP for advice.

Why Summit Therapeutics Inc. (SMMT) Skyrocketed On Monday?
Why Summit Therapeutics Inc. (SMMT) Skyrocketed On Monday?

Yahoo

time25-04-2025

  • Business
  • Yahoo

Why Summit Therapeutics Inc. (SMMT) Skyrocketed On Monday?

We recently published a list of . In this article, we are going to take a look at where Summit Therapeutics Inc. (NASDAQ:SMMT) stands against other biotech stocks that dominate Monday's top gainers. The stock market kicked off the shortened trading week on a positive note, with Wall Street's major indices finishing in the green following President Donald Trump's temporary tax reprieve on technology companies. The S&P 500 recorded the highest gain, up 0.79 percent, while the Dow Jones came second at 0.78 percent. The tech-heavy Nasdaq was also up by 0.64 percent. Benchmark indices aside, 10 companies dominated by biotechnology firms mirrored the broader market optimism, recording modest gains during the session. In this article, let us explore Monday's top 10 gainers and the reasons behind their gains. To come up with the list, we only considered the stocks with $2 billion market capitalization and $5 million trading volume. A laboratory employee in a sterile environment inspecting a microscope focused on a Clostridioides difficile infection sample. Summit Therapeutics extended its winning streak for the fourth consecutive day on Monday, adding 12.44 percent to end at $26.13 each as the company continued to ride the wave in medical stocks on optimism of lesser risks from the ongoing global trade tensions. In recent news, Cantor Fitzgerald maintained its Overweight rating on SMMT following a move by the company's co-CEO and chairman Bob Duggan to exercise warrants to acquire 4 million SMMT shares. The transaction was executed nearly four years before the warrants expired at a strike price of $1.58 apiece. Meanwhile, Truist Securities also gave the company a Buy rating and a price target of $35, representing a 50.6-percent upside from SMMT's latest closing price. SMMT is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of medicinal therapies. Overall, SMMT ranks 3rd on our list of biotech stocks that dominate Monday's top gainers. While we acknowledge the potential of SMMT as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than SMMT but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store