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- Dificid (fidaxomicin) / Merck (MSD), Astellas
Predictive Machine Learning Models for Recurrent C. difficile Infection in Inflammatory Bowel Disease Patients Based on First-Episode CDI Treatment (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_666;
Among those, 297, 85, 17 and 210 had rCDI respectively. Using the top 25 features we trained three XGBoost model.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Identifying Challenges to Harmonizing C. difficile Infection Care Among Specialties: A Critical Step as the Management Toolkit Advances (Exhibit Hall) - Jul 29, 2023 - Abstract #ACG2023ACG_647;
GIs included 61 in individual or group practices and 39 in hospital or academic centers. Most GIs are familiar with current clinical guidelines for CDI (97% very or somewhat knowledgeable).
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Review, Journal: An insight into Clostridioides difficile-associated diarrhea in Saudi children: diagnosis and treatment. (Pubmed Central) - Jul 22, 2023
Overall, pediatrics at risk of CDI recurrence should be evaluated, such as reviewing current antibiotics for potential discontinuation. Future studies evaluating the epidemiology and treatment for CDI in Saudi children are needed.
- | Vowst (fecal microbiota spores, live-brpk) / Seres Therap
FDA event, Journal: Advancing therapeutics for recurrent clostridioides difficile infections: an overview of vowst's FDA approval and implications. (Pubmed Central) - Jul 11, 2023
Furthermore, this paper will discuss the product's approval journey and the uncertainties regarding its efficacy in CDI patients beyond the ones who participated in the clinical trials, pharmacovigilance, cost estimates, and the need for a more stringent donor screening process. Overall, Vowst's approval marks a significant step forward in the prevention of recurrent CDI infections with various beneficial implications for future gastroenterology.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Re-evaluation and a Structure-Activity Relationship Study for the Selective Anti-anaerobic Bacterial Activity of Luminamicin toward Target Identification. (Pubmed Central) - Jul 7, 2023
difficile) and effective against fidaxomicin resistantC...This research indicated that the maleic anhydride and the enol ether moieties seem to be pivotal functional groups to maintain the antibacterial activity againstC. difficileand the 14-membered lactone may contribute to taking an appropriate molecular conformation.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Clostridioides (Clostridium) difficile in adults with diarrhoea in Vietnam. (Pubmed Central) - Jun 26, 2023
difficileand the 14-membered lactone may contribute to taking an appropriate molecular conformation. The prevalence of C.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Preclinical, Journal: In vivo emergence of a still uncommon resistance to fidaxomicin in the urgent antimicrobial resistance threat Clostridioides difficile. (Pubmed Central) - Jun 23, 2023
This observation supports the need for prospective surveillance of the susceptibility of C. difficile to treatment antibiotics. However, the clinical relevance of fidaxomicin resistance still needs to be elucidated, particularly due to its apparent rareness and associated fitness cost.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
"The economic model and manuscript were funded by Tillotts Pharma AG, which manufactures and distributes fidaxomicin and therefore has a financial and/or business interest in the results reported." Pffffft @BradSpellberg (Twitter) - Jun 23, 2023
- | vancomycin / Generic mfg.
Journal: The vanR Mutation 343A>G, Resulting in a Thr115Ala Substitution, Is Associated with an Elevated Minimum Inhibitory Concentration (MIC) of Vancomycin in Clostridioides difficile Clinical Isolates from Florida. (Pubmed Central) - Jun 19, 2023
In this study, we have identified a mutation (vanR 343A>G) that causes a Thr115Ala substitution and is linked to an increased MIC of vancomycin in clinical isolates of C. difficile obtained from Florida in 2016. Understanding the mechanisms of AMR, especially those of newly evolving strains, is essential to effectively guide antibiotic stewardship policies to combat antibiotic resistance as well as to discover novel therapeutic targets.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas, Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Rebyota (fecal microbiota, live-jslm) / Ferring
Review, Journal: Gut microbiota changes associated with Clostridioides difficile infection and its various treatment strategies. (Pubmed Central) - Jun 16, 2023
These include the recently FDA-approved fecal microbiota, live-jslm (formerly RBX2660) and fecal microbiota spores, live-brpk (formerly SER-109), which represent a new class of live biotherapeutic products (LBPs), traditional fecal microbiota transplantation (FMT), and ultra-narrow-spectrum antibiotics. Here, we aim to review the microbiome changes associated with CDI as well as a variety of microbiota-based treatment approaches.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-Effectiveness Analysis of Antimicrobial Prescribing in the Treatment of Clostridioides Difficile Infection in England. (Pubmed Central) - Jun 12, 2023
First-line vancomycin and second-line vancomycin was the most cost-effective treatment sequence at the NICE threshold for treating CDI in England. The main limitation of this study was that the initial cure and recurrence rates of each intervention were applied constantly across each line of treatment and each round of recurrence.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Environmental contamination with Clostridioides (Clostridium) difficile in Vietnam. (Pubmed Central) - Jun 10, 2023
Environmental sources of C. difficile are important to consider in the epidemiology of CDI in Vietnam, however, contaminated soils are likely to be the most important source of C. difficile. This poses additional challenges to controlling infections in healthcare settings.
- | Journal: Clostridium difficile in inflammatory bowel disease. (Pubmed Central) - Jun 7, 2023
Corticosteroids, unnecessary antibiotics, and ongoing colonic inflammatory disease are modifiable risk factors. Improved infection control measures, newer IBD medications, and using effective CDI treatments will facilitate a reduced burden of severe CDI and complications for IBD patients.
- | Journal: Clostridioides difficile - New Insights and Therapy Recommendations (Pubmed Central) - May 31, 2023
In addition, a new oral microbiome therapy, SER-109 (capsules containing purified Firmicutes spores), which showed promising results in a phase 3 study, may provide an easy-to-administer alternative to fecal microbiota transplantation. Hopes for a well-performing toxoid vaccine for primary and secondary prevention of CDI have unfortunately not been fulfilled in the CLOVER trial.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Retrospective data, Journal: Clostridioides difficile Infection in an Italian Tertiary Care University Hospital: A Retrospective Analysis. (Pubmed Central) - May 27, 2023
Fidaxomicin was used in 17.1% and 24.7% of cases overall and since 2019...Bezlotoxumab was administered in 64% of recurrences...We advocate for CDI notification to become mandatory and recommend coding CDI diagnosis in H-SDF to aid in infection rate monitoring. Maximum attention should be paid to preventing people on hemodialysis from getting CDI.
- | Vowst (fecal microbiota spores, live-brpk) / Seres Therap
Journal: Live fecal microbiota oral capsules (Vowst) for prevention of CDI recurrence. (Pubmed Central) - May 26, 2023
Maximum attention should be paid to preventing people on hemodialysis from getting CDI. No abstract available
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Biosynthetic Diversification of Fidaxomicin Aglycones by Heterologous Expression and Promoter Refactoring. (Pubmed Central) - May 1, 2023
In this study, an alternative biological route to afford the unique 18-membered macrolactone aglycone of fidaxomicin was developed. The promoter refactored fidaxomicin biosynthetic gene cluster from Dactylosporangium aurantiacum was expressed in the commonly used host Streptomyces albus J1074, thereby delivering five structurally diverse fidaxomicin aglycones with the corresponding titers ranging from 4.9 to 15.0 mg L. In general, these results validated a biological strategy to construct and diversify fidaxomicin aglycones on the basis of promoter refactoring and heterologous expression.
- |||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, HEOR, Cost effectiveness: And at the system level using Fidaxomicin is more cost-effective because it decreases recurrence, which leads to less sepsis, hospitalizations and deaths; which doesn’t even address the socioemotional impacts of recurrent #cdiff (Twitter) - Apr 27, 2023
- |||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: For me, no one blinks at spending $150,000 to treat cancer, but there is an expectation that infectious diseases can be treated cheaply. People can’t get Fidaxomicin prescribed because it’s $4k but patients are put through 3-4 courses of vanco and THEN Fidaxomicin, or FMT (Twitter) - Apr 27, 2023
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Evaluation of fidaxomicin use in patients with a macrolide allergy/intolerance. (Pubmed Central) - Apr 4, 2023
The promoter refactored fidaxomicin biosynthetic gene cluster from Dactylosporangium aurantiacum was expressed in the commonly used host Streptomyces albus J1074, thereby delivering five structurally diverse fidaxomicin aglycones with the corresponding titers ranging from 4.9 to 15.0 mg L. In general, these results validated a biological strategy to construct and diversify fidaxomicin aglycones on the basis of promoter refactoring and heterologous expression. No abstract available
- Zinplava (bezlotoxumab) / Merck (MSD)
EFFICACY OF BEZLOTOXUMAB IN CANCER PATIENTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION (South Hall A, Poster Hall - McCormick Place) - Mar 23, 2023 - Abstract #DDW2023DDW_2988;
Our study demonstrates that the use of bezlotoxumab in conjunction with antibiotics is efficacious in reducing CDI recurrence in the cancer population. For those who failed bezlotoxumab, FMT remains a viable option in achieving remission.
- | Rebyota (fecal microbiota, live-jslm) / Ferring
Journal: Live fecal microbiota (Rebyota) for prevention of CDI recurrence. (Pubmed Central) - Mar 7, 2023
For those who failed bezlotoxumab, FMT remains a viable option in achieving remission. No abstract available
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Conventional versus extended-pulsed fidaxomicin dosing in patients at high risk of recurrence of Clostridioides difficile infection: a propensity score analysis. (Pubmed Central) - Mar 7, 2023
Although the recurrence rate with FEPD was numerically lower than that observed with FCD, we have not been able to show that the recurrence rate of CDI is different depending on the dosage regimen of fidaxomicin. Clinical trials or large observational studies comparing the two dosing regimens of fidaxomicin are needed.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Successful treatment of recurrent Clostridioides difficile infection by administration of crushed fidaxomicin via gastro-jejunal tube. (Pubmed Central) - Mar 4, 2023
Clinical trials or large observational studies comparing the two dosing regimens of fidaxomicin are needed. No abstract available
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: We have performed several studies on C diff in Brazil… fortunately we do not have 027 strain circulating here as you have in US. C diff in Brazil is pretty similar to the epidemiology of US in years 2000 and metronidazole still works pretty well… 🙏 we dont have fidaxomicin (Twitter) - Feb 26, 2023
- || Review, Journal: Controversies in the Prevention and Treatment of Clostridioides difficile Infection in Adults: A Narrative Review. (Pubmed Central) - Feb 25, 2023
Bezlotoxumab is another attractive option to prevent recurrences. Further head-to-head studies of newer agents will be needed to guide selection of the optimal therapies for CDI primary and secondary prophylaxis.
- || vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Unfortunately it comes down to the $: "Fidaxomicin 200 mg BIX x 10 days at $2,200 vs Vancomycin 125 mg -500 mg QID x 7-10d $158 to $900 and Metronidazole 250 mg QID orr 500 mg TID for 10 -14 days $2- $30. (Twitter) - Feb 21, 2023
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Reimbursement, US reimbursement: The guideline was written before approval of fidaxomicin for kids (that's why it's not there!). Lower recurrence than vanco but not ⬆️initial response- utility likely highest when >1 prior recurrence, but cost still prohibitively high so need to consider insurance coverage etc. (Twitter) - Feb 16, 2023
- | Zinplava (bezlotoxumab) / Merck (MSD)
Journal: Bezlotoxumab Therapy for Recurrent Clostridium difficile Infection in an Ulcerative Colitis Patient. (Pubmed Central) - Feb 14, 2023
The patient's symptoms improved, inflammatory markers normalized, and she has remained asymptomatic for twelve months. This case supports the findings in the MODIFY I/II trials that Bezlotoxumab is a viable treatment option of rCDI in IBD patients.
- | metformin / Generic mfg.
Journal: A case of recurrent Clostridium difficile infection with type 2 diabetes mellitus indicating the usefulness of metformin hydrochloride (Pubmed Central) - Feb 12, 2023
Till approximately two years after discharge, no recurrence was observed. Here metformin hydrochloride was suggested to be useful for the treatment of recurrent CDI with type 2 diabetes mellitus.
- Dificid (fidaxomicin) / Merck (MSD), Astellas, Valcyte (valganciclovir) / Roche, Mitsubishi Tanabe, Cytovene (ganciclovir) / Roche
CLOSTRIDIUM DIFFICILE INFECTION, CYTOMEGALOVIRUS REACTIVATION AND GASTROINTESTINAL GRAFT VERSUS HOST DISEASE IN RECIPIENTS OF ALLOGENEIC STEM CELL TRANSPLANTATION (ePoster Area) - Feb 11, 2023 - Abstract #EBMT2023EBMT_1498;
Here metformin hydrochloride was suggested to be useful for the treatment of recurrent CDI with type 2 diabetes mellitus. Treatment of CDI started with oral Vancomycin and Metronidazole, for CMV with oral Valganciclovir, and for Gastrointestinal (GI) aGVHD except cyclosporine A (CsA) added mycophenolate mofetil (MMF), budesonide, and steroid...Due to immunosuppressive therapy, CMV reactivated the second time, and ganciclovir started, leading to pancytopenia, and developed sepsis...Fidaxomicin has been used to treat CDI, unfortunately, it hasn
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Efficacy of lyophilised bacteria-rich faecal sediment and supernatant with reduced bacterial count for treating patients with Clostridioides difficile Infection - A novel method for capsule faecal microbiota transfer. (Pubmed Central) - Feb 10, 2023
Faecal microbiota transfer (FMT) has managed to earn its place in the Clostridioides difficile infection (CDI) guidelines by having comparable efficacy and recurrence rate of fidaxomicin...A significantly lower CFU number was sufficient for the effect, the separation can be achieved by widely available instruments. For storage temperature, -20
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Pricing, HEOR: The authors estimate the pricing required for fidaxomicin to be cost saving through preventing recurrence at $1140 USD and $860 CAD, respectively https://t.co/hC7ayLaPs0 @DrToddLee @ASPphysician @DrEmilyMcD @BrentFooter @AntibioticDoc @BradSpellberg #JACAMRNews (Twitter) - Feb 7, 2023
- Leaking bowel syndrome: a rare case of co-infection with Clostridioides difficile and cytomegalovirus in a non-HIV patient (C / 01) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_5279;
- Impact of national C. difficile infection guidelines on national prescribing: experience from English prescribing data (A / 15) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4306;
- ibezapolstat (ACX-362E) / Acurx Pharma
Novel pharmacology and susceptibility of ibezapolstat against Clostridiodes difficile isolates with reduced susceptibility to C. difficile -directed antibiotics (A / 04) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_4037;
- Fecal microbiota, another bites the dust (C / 15) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2689;
- Variation in Clostridioides difficile infection (CDI) management across Europe (C / 13) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2682;
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Evaluation of fidaxomicin availability and use for Clostridioides difficile infection upon transition of care (C / 13) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2677;
- Czech national guidelines for diagnosis and treatment of Clostridioides difficile infections 2022 (C / 13) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2675;
- Risk factors for recurrent Clostridioides difficile infections among solid organ transplant recipients: results from the observational international CALIPSO study (C / 15) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2657;
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Experience with fidaxomicin in Clostridoides difficile infection in a retrospective case-control study (C / 15) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2653;
- A decade of Clostridioides difficile infection: a constant challenge despite intensive multi-disciplinary input (C / 15) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_2651;
- Microbiota resilience after Clostridioides difficile infection treatments (Hall D) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_1697;
- The HYPOTHETICAL trial: a HYPOTHEtical TrIal of Clostridioides difficile infection treatment ALgorithms (Arena 4) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_878;
- Clostridioides difficile resistance to primary treatment antibiotics: molecular and phenotypic epidemiology (Arena 1) - Feb 4, 2023 - Abstract #ECCMID2023ECCMID_768;
- Dificid (fidaxomicin) / Merck (MSD), Astellas, Gamunex-C (human immune globulin 10%- caprylate/ chromatography purified) / Kedrion, Grifols
INTRAVENOUS IMMUNOGLOBULIN (IVIG) FOR SEVERE OR FULMINANT CLOSTRIDIUM DIFFICILE INFECTION () - Jan 25, 2023 - Abstract #SCCM2023SCCM_1403;
Various dosing strategies were utilized, limiting assessment of a dose-response relationship. Further data and a comparison to a cohort of critically ill patients who did not receive IVIG is needed to delineate place in therapy.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Fidaxomicin to prevent recurrent Clostridioides difficile: what will it cost in the USA and Canada? (Pubmed Central) - Jan 13, 2023
The probability that fidaxomicin was cost saving exceeded 95% if priced below $1140USD or $860CAD, respectively. An increased drug expenditure on fidaxomicin may not be offset through recurrence prevention unless the fidaxomicin price is negotiated.
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
🔥Ohh Finally @DrToddLee 🔥 With the 🌟 @DrEmilyMcD 🆕️⚡️ @jac_amr @davidvanduin Fidaxomicin to prevent recurrent Clostridioides difficile: what will it cost in the USA and Canada? #IDTwitter https://t.co/JdHC4TnAy7 (Twitter) - Jan 7, 2023
- Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Clostridioides difficile Guidelines (Moscone Center South - 204) - Jan 4, 2023 - Abstract #SCCM2023SCCM_891;
Recent updates to the clinical practice guidelines for C. difficile infection by the Infectious Diseases Society of America (IDSA) and the American Gastroenterology Association (AGA) have added new complexity to the management of this common nosocomial infection. In this session, we will review the role of fidaxomicin as potential first-line therapy, discuss the role of bezlotoxumab in relapse, and determine timing for surgical consultation for fulminant disease.