Latest news with #C.difficile
Business Wire
3 days ago
- Health
- Business Wire
Vedanta Biosciences Announces Phase 2 Study of VE202 in Ulcerative Colitis Did Not Meet Primary Endpoint
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vedanta Biosciences, a late clinical-stage biopharmaceutical company developing microbiome-based oral therapies for gastrointestinal diseases, today announced that its candidate VE202 did not meet the primary endpoint of endoscopic response in the Phase 2 COLLECTiVE202 study for the treatment of patients with mild-to-moderate ulcerative colitis (UC). 'We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option,' said Bernat Olle, Ph.D., Chief Executive Officer of Vedanta Biosciences. 'The gut microbiome is a well-recognized driver of IBD, yet remains a facet of the disease untouched by current treatments. As a field, we have not yet succeeded in making a meaningful impact for people with IBD through microbiome-based approaches, but every study moves us closer to that goal. We are committed to sharing further analyses of this study at upcoming scientific meetings to help chart new paths forward.' 'Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved Live Biotherapeutic Product in any indication — and, in doing so, addressing a serious health condition with a significant unmet medical need,' concluded Dr. Olle. In the randomized, placebo-controlled COLLECTiVE202 study, endoscopic and clinical responses were assessed using standardized criteria, and the observed response rates in the VE202 group were not statistically different from those in the placebo group. VE202 was generally safe and well tolerated — most adverse events were mild or moderate in intensity, with no reports of treatment-related serious adverse events. Analyses of bacterial colonization, histological findings, and immune responses are ongoing and will be shared in future scientific forums. Vedanta remains focused on advancing its other pipeline programs: VE303: Vedanta is currently enrolling patients into RESTORATiVE303, a registrational Phase 3 study of VE303 for the prevention of recurrent C. difficile infection (rCDI) at over 200 sites in 24 countries. The Phase 3 program is supported by results from a positive Phase 2 study, in which VE303 demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk reduction compared with placebo and greater than 80% reduction in the odds of a CDI recurrence. VE707: Vedanta is also advancing VE707 to prevent infections by multidrug-resistant organisms that affect a wide range of vulnerable populations in areas such as oncology, urology, transplantation, and critical care, with IND submission planned for 1H 2026. About the COLLECTiVE202 Study COLLECTiVE202 is a double-blind, placebo-controlled, randomized clinical trial conducted at sites in the United States, Europe, and Australia. The study enrolled 114 patients, between the ages of 18 and 75 years, with mild-to-moderate ulcerative colitis who had not been exposed to any biologic or advanced oral therapies. Either VE202 (N=57) or placebo (N=57) was added to a patient's stable background ulcerative colitis therapy. The primary endpoints were safety and Week 8 endoscopic response (defined as a reduction of at least 1 point on the Mayo endoscopic subscore). Secondary endpoints included clinical response and remission, endoscopic improvement and remission, as well as histological assessments and measures of colonization, quality-of-life and inflammatory biomarkers. For more information on COLLECTiVE202 (NCT05370885), visit About Vedanta Biosciences Vedanta Biosciences is a clinical-stage biopharmaceutical company developing microbiome-based oral medicines for the treatment of gastrointestinal diseases. The company's lead asset is a potential first-in-class therapy, VE303, currently in a global Phase 3 registrational trial for prevention of recurrent C. difficile infection. Vedanta leverages its proprietary industry-leading product engine to develop therapeutic drug candidates based on defined bacterial consortia. The product engine is supported by broad foundational intellectual property and spans the development lifecycle from discovery to commercialization. It includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.
Time Business News
22-07-2025
- Health
- Time Business News
Transforming Hospital-Acquired Infection Detection
The hospital acquired disease testing refers to clinical procedures, which are used to detect infection that patients are contracted while staying in the hospital, such as MRSA, C. difficile, sepsis, and ventilator-associated pneumonia. The market testing for the market is increasing due to increasing incidence of infections associated with healthcare, increased antimicrobial resistance, and rapid, to prevent outbreaks and improve patient results. Additionally, progress in point-of-care tests, molecular diagnosis and transition control protocols is accelerating adoption in healthcare facilities worldwide. Key Growth Drivers and Opportunities Increasing Incidence of Infections Associated with Healthcare: Increasing incidence of healthcare infections-as M MRSA, C. difficile, and ventilator-associated pneumonia is a major driver, a major driver, which is the test market. These infections not only increase the cost of patient sickness and health care, but also demand more accurate clinical solutions to enable timely intervention and control. As hospitals strive to meet strict transition control rules and improve the patient's results, the need to be reliable continues to increase testing technologies, promoting market expansion. Challenges Hospital acquired disease (HAD) tests faces several borders, including high costs associated with advanced molecular diagnosis, limited availability of rapid point-care solutions in resource-settings, and capacity for false positive or negative due to sample contamination or sample contamination or low pathogen load. Additionally, in traditional laboratory-based methods, test results may obstruct clinical decisions on time. The lack of standardized testing protocols in institutions and complicate the increasing risk of antimicrobial resistance and complicate more accurate diagnosis and treatment, faced challenges for effective infection controls. Innovation and Expansion Hospital-Acquired Infection Monitoring is Being Transformed by Decentralized Diagnostics In November 2024, The Azienda Ospedaliero-Universitaria Careggi hospital and Don Gnocchi, a rehabilitation facility in Florence, Italy, have teamed together to establish an infection prevention and control approach. The Don Gnocchi Foundation spearheaded their efforts by installing a Cepheid GeneXpert technology for screening carbapenemase-producing enterobacterales (CPE) on-site. Microbiologists from the Azienda Ospedaliero-Universitaria di Careggi then remotely and in real time confirm the results improved infection prevention and control, improved patient care, and total cost savings for the Don Gnocchi Foundation are all made possible by this methodology. Southern Ohio Medical Center Uses MEDITECH Expanse to Reduce C. difficile Rates by 30% In August 2022, Hospital-acquired C. difficile infections have decreased by 30% and test cancellations have decreased by 32% at Southern Ohio Medical Center (Portsmouth, OH). These outstanding accomplishments were the result of MEDITECH Professional Services (MPS) and SOMC's Quality Improvement Team working together to enhance patient outcomes, increase evidence-based treatment, and expedite the time-consuming, ineffective testing procedures. As part of its ongoing efforts to maintain high quality metrics on a publicly published measure, SOMC demonstrated a 30% relative decrease in hospital-acquired C. difficile. This helped the company avoid fines based on value-based payment models and boost customer confidence. By improving antibiotic prescribing procedures, this program has also aided their antimicrobial stewardship initiatives. Inventive Sparks, Expanding Markets Major development strategies for hospital acquired disease testing companies include rapid point-off-care and multiplex test platforms, strategic partnerships with hospitals and public health agencies, investing in AI-powered clinical equipment, regular approval for new assays and targeting emerging markets with scalable, low-cost solutions. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
Yahoo
09-06-2025
- Business
- Yahoo
Acurx Pharmaceuticals Announces Presentation of Results from Leiden University Medical Center Public-Private Partnership for Its DNA pol IIIC Inhibitors at the Federation of American Societies for Experimental Biology Scientific Conference
Results are from Acurx's ongoing scientific collaboration with Leiden University Medical Center (LUMC) partially under a grant from Health Holland to further study the mechanism of action of DNA pol IIIC inhibitors LUMC highlighted Acurx's new class of promising antimicrobials, ibezapolstat and related analogues Novel chemotype specifically targeting gram-positive bacteria through an unexploited target Ibezapolstat ready to enter pivotal Phase 3 clinical trials for C. difficile Infection (CDI), with no cross resistance reported to date Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designations and has received SME (Small and Medium-sized Enterprise) designation by the EMA STATEN ISLAND, N.Y., June 9, 2025 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. Its lead antibiotic candidate, ibezapolstat (IBZ), is ready to advance to international pivotal Phase 3 clinical trials for treatment of patients with C. difficile infection (CDI). The Company today announced that a presentation of a poster and an oral presentation regarding Acurx's overall DNA pol IIIC inhibitor platform was presented at a scientific conference on May 21 by Mia Urem, PhD, from Leiden University Medical Center in the Netherlands entitled: "A Unique Inhibitor Conformation Selectively Targets the DNA Polymerase PolC of Gram-Positive Priority Pathogens". This scientific conference is sponsored by the Federation of American Societies for Experimental Biology and is the premier venue for the newest research and technological trends in molecular "machines" inside the human body that ensure DNA replication and expression of genes to create proteins that make up a cell. The distinctive non-planar conformation of ACX-801 and IBZ, together with high conservation of the induced binding pocket in PolC, suggests that this is a general mechanism for this class of inhibitor and is conserved in Gram-positive bacteria. According to Dr. Wiep Klaas Smits, Associate Professor/Principal Investigator, Leiden University Medical Center: "Our findings with regards to the structural biology of DNA pol IIIC in complex with inhibitors have important implications for the development of this novel class of antibiotics to treat high priority, multi-drug resistant, gram-positive infections." Acurx's Executive Chairman, Bob DeLuccia, stated: "This research outcome provides a deeper understanding of the mechanism of action and selectivity of ibezapolstat in the gut. These data will guide the rational design of new compounds with improved inhibitory activity and drug-like characteristics that will be crucial in addressing the pandemic of antimicrobial resistance." POSTER AND PRESENTATION ARE ON ACURX WEBSITE About the Federation of American Societies for Experimental BiologySince its inception 20 years ago, this conference has been the premier venue for the newest research and technological trends that aid in studying the molecular "machines" inside the human body. These biological elements ensure faithful DNA replication and expression of genes to create the many proteins that make up a cell. The Machines on Genes scientific conference covers all aspects that govern the central building blocks of life, DNA replication, transcription, and translation, as well as activities that impact these processes such as DNA repair, DNA editing, and RNA editing. There is special emphasis on how they work, how they interact with one another, and how they may be used as diagnostic tools or as targets for novel therapies. About Leiden University Medical CenterAntimicrobial resistant microorganisms are a major threat to global health and pose a significant economic burden. Increasing resistance to multiple agents and resistance to so called last-resort antibiotics underscore the necessity to develop therapeutics that have a novel mode of action. DNA replication is a process that can be successfully targeted by small molecules. Ibezapolstat, an inhibitor of the replicative DNA polymerase pol IIIC from Gram-positive bacteria identified by screening library of dGTP analogues, has shown promising results for the treatment of Clostridioides difficile Infection in a recent Phase 2a clinical trial, but the molecular basis of selective inhibition is not fully characterized as no structural information is available on pol IIIC proteins from pathogens. Ongoing research project will determine the structure of pol IIIC from the multidrug-resistant organisms methicillin resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococci (VRE) and/or penicillin resistant Streptococcus pneumoniae (PRSP) in the absence and presence of lead compounds. These results will reveal the structural space of inhibitor-binding and guide the rational design of inhibitors with optimal pharmacological properties and organism-specificity that will be demonstrated by in vitro polymerase inhibition assays and in vivo minimal inhibitory concentration determination. Leiden University was the first university to be established in the Netherlands. Its motto is praesidium libertatis – bastion of freedom. The University wishes to create an increasingly attractive and challenging working climate for top academics and young researchers that is guided by quality and excellence. Leiden University Medical Center (LUMC) research aims to meet the highest international standards of quality and academic integrity. LUMC promotes excellent research through greater collaboration, both disciplinary and interdisciplinary; stronger positioning and greater scope for top talent; and better supervision and more support for young researchers. The presented research was performed in part as a public-private partnership that includes the Dutch Top Sector Life Sciences and Health ('Topconsortium voor Kennis en Innovatie' or 'TKI' Life Sciences and Health) and is represented by Stichting Life Sciences Health – TKI (aka, Health~Holland). This foundation is tasked by the Dutch government to promote and stimulate public-private partnerships (PPPs) to undertake R&D projects in the life sciences. To promote such partnerships, the Minister of Economic Affairs and Climate Policy has allocated certain funds to Stichting LSH-TKI, to grant allowances to projects under the TKI-programme Life Sciences & Health. Stichting LSH-TKI has designated the Board of Directors of LUMC as delegated grantor for the PPP allowance allocated to the LUMC. Together with Acurx Pharmaceuticals the PPP has led to the research project entitled "Bad bugs, new drugs: elucidation of the structure of DNA polymerase C of multidrug resistant bacteria in complex with novel classes of antimicrobials." The collaboration project was co-funded by the PPS Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to stimulate public-private partnerships. Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application (MAA) for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program. The primary efficacy analysis will be performed using a Modified Intent-To-Treat (mITT) population. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard- of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. About the Ibezapolstat Phase 2 Clinical TrialThe completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline. from study centers in the United States. In the Phase 2a trial segment,10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment (10 of 10). In the Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. In the Phase 2b trial, the Clinical Cure rate in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Notably, in the combined Phase 2 trial, 100% (25 of 25) ibezapolstat-treated patients ) who had Clinical Cure at EOT) (End of Treatment) remained cured through one month after EOT, as compared to 86% (12 of 14) for the vancomycin patient group. Ibezapolstat was well-tolerated, with no serious adverse events assessed by the blinded investigator to be drug- related. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96%, Sustained Clinical Cure Rate of 100% and the historical vancomycin Clinical Cure Rate range of 70% to 92% and a Sustained Clinical Cure historical range of 42% to 74%, we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials, in accordance with the applicable FDA Guidance for Industry (October 2022), with favorable differentiation in both Clinical Cure and Sustained Clinical Cure. In the Phase 2 clinical trial (both trial segments), the Company also evaluated pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin. The company also reported positive extended clinical cure (ECC) data for ibezapolstat (IBZ), its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. This exploratory endpoint showed that 5 of 5 IBZ patients followed for up to three months following Clinical Cure experienced no recurrence of infection. Furthermore, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients. About IbezapolstatIbezapolstat is the Company's lead antibiotic candidate planning to advance to international Phase 3 clinical trials to treat patients with C. difficile infection. Ibezapolstat is a novel, orally administered antibiotic, being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI. About Clostridioides difficile InfectionAccording to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, 2015, NEJM). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, NEJM. Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%. About the Microbiome in C. difficile Infection and Bile Acid MetabolismC. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa. Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (Garey, CID, 2022). In the Ph2b trial, ibezapolstat-treated patients showed lower concentrations of fecal primary bile acids, and higher beneficial ratio of secondary to primary bile acids than vancomycin-treated patients. About Acurx Pharmaceuticals, Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram-positive specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen). Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection is Phase 3 ready with plans in progress to begin international clinical trials next year. The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel. To learn more about Acurx Pharmaceuticals and its product pipeline, please visit Forward-Looking StatementsAny statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2024, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law. Investor Contact: Acurx Pharmaceuticals, Inc.; David P. Luci, President & CEO Tel: 917-533-1469; Email: davidluci@ View original content: SOURCE Acurx Pharmaceuticals, Inc.
The Herald Scotland
03-06-2025
- Politics
- The Herald Scotland
Call for law changes to ensure ScotGov public inquiries are effective
It has come as it emerged the Scottish Government has admitted there is no legal requirement to monitor whether lessons learnt recommendations from inquiries are actually acted on. Those inquiries cover 20 years and range from the Edinburgh Tram Inquiry, the Vale of Leven Inquiry investigation into the occurrence of C. difficile infection to the the Stockline inquiry into the 2004 explosion at the ICL Plastics factory in Glasgow and the public investigation into the integrity of the fingerprint service. The current cost of all live inquiries has soared thirteen-fold over ten years to stand at nearly £180m and it is estimated the overall costs has reached nearly £250m since 2007. The cost of the five live major inquiries that are currently running eclipses the solitary one that was live ten years ago - and even those costs are spiralling. At the start of last year the live inquiries were costing £120m. Ten years ago the solitary major inquiry at the time into the Edinburgh Tram project came at a total cost of £13m. It was set up to establish why the capital's trams project incurred delays, cost more than originally budgeted and delivered significantly less than was projected. Edinburgh Trams were subject of an inquiry into soaring costs and delays But there are concerns that overall cost figures for inquiries could well be a lot higher as they do not include the costs to government departments, other public bodies and those participating. The Scottish Government was asked by a group of MSPs how many of the 197 recommendations, including 11 interim and a plan of action from a series of public inquiries since 2007 were implemented and what its role is in monitoring and ensuring lessons are learnt. But they were told that the law does not require ministers to act as overseer in this area, even though under the Inquiries Act 2005, the chairman of an inquiry must provide a final report to the ministers, setting out the facts determined by the inquiry panel and any recommendations where its terms of reference lay that out. Deputy First Minister Kate Forbes, response to questions about which recommendations were actioned did not spell out what of the 200 lessons were actually acted upon from inquiries formally established by ministers. READ MORE by Martin Williams: Why does Scotland hold costly 'lessons learnt' public inquiries Ministers warned over public inquiries secrecy as taxpayer cost soars by £60m in a year Swinney urged to act over 'stalled' lifeline funding of ferry fiasco firm Revealed: £400k public cost of ScotGov Euro 2028 ticket tout ban that 'won't work' 'People going bananas': New ferry fiasco hits vital island supplies 'Stretched to breaking': Nation loses 800 officers since formation of Police Scotland Instead she states that the Act "does not contain any provision for centrally monitoring over whether the accepted inquiry recommendations are actually implemented". And she added: "There is no legal obligation to respond to a report." The questions related to recommendations of concluded public inquiries since 2007, and also include the Penrose infected blood probe. She further states in answer to questions about what lessons have been learnt, that in practice, an area of government "will be identified as responsible for taking forward recommendations (where appropriate) and ensuring delivery where they are accepted". She said recommendations may also be made by an inquiry relating to other parties, such as public bodies, "which would be for their consideration". The current cost of the two live inquiries into health-related issues including the Covid-19 pandemic currently stands at £64.3m. There were no live health-related public inquiries ten years ago, although in the decade previously, there were two which together cost £22.8m. Over £12m of legal and administrative costs has been incurred by NHS bodies alone responding to public inquiries since 2021. NHS National Services Scotland (NSS) which is a core participant in the long-running Scottish Covid-19 pandemic inquiry and has participated in two further public probes says it has spent £3.1m since 2021/22 in responding to public inquiries through legal and other administrative costs. On top of that a further £9m in legal services for public inquiries was provided to NHS Scotland boards by the NSS's Central Legal Office. NSS, which reports directly to the Scottish Government, and works at the heart of Scotland's health service, providing national strategic support services and expert advice to NHS Scotland, suggested an independent advisory body could be established to decide whether a public inquiry should be held and hold to account those probes that did go ahead. It suggested that the current processes for monitoring public inquiry costs are "inadequate" saying that they are not reimbursed "or reported consistently". The NSS said that the advisory body could have a role in assessing the costs. "Tight terms of reference are essential when a public inquiry is established to ensure value for money" they said. NSS said that the inquiries' effectiveness "can vary considerably". It said that work was needed to look at each concluded inquiry in Scotland against its terms of reference and examine what the has been achieved. It said that that would allow effectiveness "to be measured in more detail". It said a new advisory body could examine what opportunities there area for learning lessons, whether it would be effective and whether it would be value for money. It could also ensure a consistency of approach and oversee costs that are incurred. And it suggested that a law could be introduced to ensure that lessons are learnt from public inquiries, indicating that in terms of lessons learnt "consistency and cascading out can be challenging". The independent advisory body could "support consistency in cascading lessons learned". Section 28 of the Fatal Accidents and Sudden Death etc (Scotland) Act 2016 introduced a requirement that those to whom recommendations are directed must provide a response within eight weeks to set out what changes have been made or are proposed. Alternatively it has to provide the reasons why no action is being taken. It suggested a similar law that is brought in for public inquiries "requiring participants in public inquiries to report to parliament with their written response to the inquiries' reports". Lord Hardie, the man in charge of the Edinburgh tram probe has admitted there were limitations when inquiries like the one he oversaw was established by the Scottish Government as non-statutory, which he says he was not consulted over. He has said in correspondence seen by the Scottish Government that this led to him being unable to access material held by the City of Edinburgh Council and resulted in the refusal of key witnesses to co-operate. The most expensive and longest running of the current probes is the Scottish Child Abuse Inquiry into historical abuse of children in residential care that was formally established in October 2015 - ten months after the Scottish Government announced that it would happen. Concerns have been raised about delays and mounting costs - which was running at £78.211m at the start of last year and has risen to £95.3m as of March 2025. The second most expensive live public probe is the Scottish Covid-19 inquiry which started in August 2022 to examine Scotland's response to and the impact of the pandemic and to learn lessons for the future. It had run up costs of £12.816m by the start of last year. And by December last year it was at £34m. The Scottish Hospitals Inquiry chaired by Lord Brodie QC which is examining issues of safety and wellbeing issues at two Scots health establishments had cost £14.33m at the start of last year after opening in August 2020. It had risen to £23.6m in December 2024. It is examining complaints around the Queen Elizabeth University Hospital (QEUH) in Glasgow, and the Royal Hospital for Children and Young People (RHCYP) and Department of Clinical Neurosciences in Edinburgh. Its final report is expected to be issued at the end of next year after calls for further evidence. The latest inquiry into Sam Eljamel, who harmed dozens of patients and left some with life-changing injuries, was launched last month and has racked up £1.08m in costs so far - before hearing any evidence. Mr Eljamel was head of neurosurgery at Dundee's Ninewells Hospital until his suspension in December 2013. He resigned a year later and is now believed to be operating in Libya. At the start of last year, the Herald revealed the cost of live inquiries at that point was at £120m, while the Scottish Parliament launched an inquiry last month into their cost effectiveness last month. MSPs are to further consider the role of public inquiries today. Research suggests the total cost of all public inquiries launched over the last 18 years, in today's prices, is at £230m so far. A Scottish Government spokesperson said: 'Public inquiries are set up when no other avenue is deemed sufficient given the issues of public concern. In many cases, such as the Scottish Covid Inquiry, they are set up with the support of, or in response to calls from, the Scottish Parliament. "Public inquiries operate independently of government and the chair has a statutory duty to avoid unnecessary costs.'
Los Angeles Times
22-05-2025
- 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. 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