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11 Diseases |  |
2 Trials |
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2 Trials |  |
1263 News |  |
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- || Dificid (fidaxomicin) / Merck (MSD), Astellas
If covered then fidaxomicin, but mostly because vanc taper is arduous to both rx and take (Twitter) - Jun 4, 2022
- || vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Just to make it a bit controversial, 1st episode treated with PO vancomycin, for the 2nd episode would you use vanco with taper or just jump ahead to fidaxamicin (if there is no issues with coverage) and would you use a short course or extended pulsed fidaxomicin #IDTwitter? (Twitter) - Jun 4, 2022
- Dificid (fidaxomicin) / Merck (MSD), Astellas, cerulenin / Fermentek
The Fatty Acid Biosynthesis Isoenzyme Fabk Is A Target For Narrow-spectrum Antibiotics For Clostridioides Difficile Infection (Exhibit and Poster Hall) - Jun 4, 2022 - Abstract #ASMMicrobe2022ASM_Microbe_2815;
With the increasing spread of the strains exhibiting resistance to vancomycin and metronidazole and the emergence of resistance to fidaxomicin, there is a need for new Clostridioides difficile infection (CDI) antimicrobials...The relative abundance of trans-2-acyl-ACP was significantly higher in the samples treated with 296, as compared to cerulenin (FabB/FabF inhibitor)...These observations support the progression of 296 to ongoing efficacy studies in the murine model of CDI colitis and investigate its effects on gut microbiota composition in mice by metagenomics. These studies suggest that FabK has the potential to be a narrow-spectrum drug target, warranting further discovery-oriented attention.
- Dificid (fidaxomicin) / Merck (MSD), Astellas, cerulenin / Fermentek
The Fatty Acid Biosynthesis Isoenzyme Fabk Is A Target For Narrow-spectrum Antibiotics For Clostridioides Difficile Infection (Exhibit and Poster Hall) - Jun 4, 2022 - Abstract #ASMMicrobe2022ASM_Microbe_2814;
With the increasing spread of the strains exhibiting resistance to vancomycin and metronidazole and the emergence of resistance to fidaxomicin, there is a need for new Clostridioides difficile infection (CDI) antimicrobials...The relative abundance of trans-2-acyl-ACP was significantly higher in the samples treated with 296, as compared to cerulenin (FabB/FabF inhibitor)...These observations support the progression of 296 to ongoing efficacy studies in the murine model of CDI colitis and investigate its effects on gut microbiota composition in mice by metagenomics. These studies suggest that FabK has the potential to be a narrow-spectrum drug target, warranting further discovery-oriented attention.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Membrane Cholesterol Guards Gut Epithelial Resistance to Clostridioides Difficile Infection (Exhibit and Poster Hall) - Jun 4, 2022 - Abstract #ASMMicrobe2022ASM_Microbe_2538;
Administration of the MβCD to deplete membrane cholesterol improved the phenotypes of CDI, including bodyweight loss, inflammation, and intestinal permeability. Taken together, these results demonstrate that cholesterol depletion is a potential strategy to diminish C. difficile SLPs mediated colonization and induced inflammasome activation.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Fidaxomicin with taper (Twitter) - Jun 4, 2022
- ||| Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: 3rd: fidaxomicin 25 consideration and Bezlotuximab if able. FMT hesitant in patient on Remicade (Twitter) - Jun 4, 2022
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Pricing: "Current drug pricing, est additional cost of 10d course fidaxomicin compared to vanc to prevent 1 recurrence was $46,178USD (95%CI $36,942-$69,267) & $13,760CAD (95%CI $11,008-$20,640). Est mean systemic cost of CDI recurrence $14,506USD & $8,588CAD." Wow... (Twitter) - Jun 4, 2022
- ||||| vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: Discussing C.diff infections in #IBD today at @acadeciencias https://t.co/rWb0k8qWj3 Top Tips; 🤝 two step testing (not PCR only) 🥇1st vancomycin or fidaxomicin 🤝 Rx IBD in parallel in most cases 🔥 bile acids impact 🧫 growth ( 🙁 not in Girona to join event) (Twitter) - Jun 3, 2022
- ||| vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Reimbursement, Medicare: Fidaxomicin emerged favorable to vancomycin for C diff infections in a Medicare population. #DDW2022 https://t.co/cEjlfIxiMn (Twitter) - May 30, 2022
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Impact of Subinhibitory Concentrations of Metronidazole on Morphology, Motility, Biofilm Formation and Colonization of Clostridioides difficile. (Pubmed Central) - May 30, 2022
Weak doses of MTZ induced higher level of colonization in the conventional mouse model and a trend to thicker 3-D structures entrapping bacteria in monoxenic mouse model. Thus, sub-inhibitory concentrations of MTZ can have a wide range of physiological effects on bacteria, which may contribute to their persistence after treatment.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Identification of Potential RBPJ-Specific Inhibitors for Blocking Notch Signaling in Breast Cancer Using a Drug Repurposing Strategy. (Pubmed Central) - May 30, 2022
Finally, an FDA-approved antibiotic, fidaxomicin, was identified as a potential RBPJ inhibitor, and its ability to block RBPJ-dependent transcription and thereby inhibit breast cancer growth was experimentally verified. Our study demonstrated that fidaxomicin suppressed Notch signaling and may be repurposed for the treatment of breast cancer.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Nitro-Group-Containing Thiopeptide Derivatives as Promising Agents to Target Clostridioides difficile. (Pubmed Central) - May 30, 2022
Its time-kill kinetics against a hypervirulent C. difficile ribotype 027 and in vivo (mouse) efficacy compare favorably to vancomycin, and they define AJ-024 as a valuable platform for the development of new anti-C. difficile antibiotics.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Clostridioides (Clostridium) difficile in children with diarrhoea in Vietnam. (Pubmed Central) - May 26, 2022
The prevalence of C. difficile in children with diarrhoea was high (37.8%) although the proportion of toxigenic strains was comparatively low. The clinical significance of any isolate needs to be determined.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Defining optimal treatment for recurrent Clostridioides difficile infection (OpTION study): A randomized, double-blind comparison of three antibiotic regimens for patients with a first or second recurrence. (Pubmed Central) - May 26, 2022
P4
CSP study 596 is designed to compare three current antibiotic treatments for recurrent CDI that are in clinical practice, but which lack high-quality evidence to support strong guideline recommendations. The design of the study which included a pilot phase initiated at six sites with expansion to 24 sites is described along with protocol modifications based on early trial experience and clinical realities including the COVID-19 pandemic.
- | Mycobutin (rifabutin) / Pfizer, Lupin, Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: 6S RNA-Dependent Susceptibility to RNA Polymerase Inhibitors. (Pubmed Central) - May 20, 2022
Nevertheless, its protective effect against rifampicin is independent of alternative sigma factor σ activity. Our results suggest that 6S RNA helps maintain RNAP-σ integrity in S. aureus, which could in turn help bacteria withstand low concentrations of RNAP inhibitors.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Risk of Clostridioides Difficile Infection After Kidney Transplant (Hynes Halls C & D: Board No. B065) - May 20, 2022 - Abstract #ATC2022ATC_2834;
This important risk factor highlights the need to evaluate CDI prophylaxis, with oral vancomycin or fidaxomicin, in this population. Further investigation regarding the association between pre-transplant CDI and delayed graft function is warranted.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Probiotics: insights and new opportunities for Clostridioides difficile intervention. (Pubmed Central) - May 17, 2022
The use of live commensal microorganisms, or probiotics, is one of the most investigated non-antibiotic therapeutic options to balance gastrointestinal (GI) microbiota and subsequently tackle dysbiosis. In this review, we will discuss major commensal probiotic strains that have the potential to prevent and/or treat CDI and its recurrence, reassess the efficacy of probiotics supplementation as a CDI intervention, delve into lessons learned from probiotic modulation of the immune system, explore avenues like genome-scale metabolic network reconstructions, genome sequencing, and multi-omics to identify novel strains and understand their functionality, and discuss the current regulatory framework, challenges, and future directions.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Clostridioides difficile surface layer protein triggered inflammasome activation is mediated by membrane lipid raft. (Pubmed Central) - May 14, 2022
The coalescence of SLPs in the cholesterol-rich microdomains was confirmed in C. difficile-infected cells. Our results demonstrate that SLPs recruit the lipid rafts, which may be a key step for C. difficile colonization and inducing inflammasome activation.
- || Zinplava (bezlotoxumab) / Merck (MSD)
Clinical, Journal, Real-world evidence: Real-World Comparison of Bezlotoxumab to Standard of Care Therapy for Prevention of Recurrent Clostridioides difficile Infection in Patients at High Risk for Recurrence. (Pubmed Central) - May 11, 2022
Our results demonstrate that SLPs recruit the lipid rafts, which may be a key step for C. difficile colonization and inducing inflammasome activation. BEZ is effective for the prevention of rCDI and reduction in all-cause hospital readmission for patients at high risk for recurrence, supporting current guideline recommendations.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: The development of live biotherapeutics against Clostridioides difficile infection towards reconstituting gut microbiota. (Pubmed Central) - May 10, 2022
The use of antibiotics causes gut microbiota dysbiosis and shifts the status from colonization resistance to infection. Hence, novel CDI biotherapeutics capable of reconstituting normal gut microbiota have become a focus of drug development in this field.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Review, Journal: Fulminant Clostridioides difficile Infection: A Review of Treatment Options for a Life-Threatening Infection. (Pubmed Central) - May 6, 2022
Several nonantibiotic therapies, including fecal microbiota transplantation and intravenous immunoglobulin, have shown success as adjunctive therapies, but they are unlikely to be effective alone. In this review, we aim to summarize diagnosis and treatment options for FCDI.
- SER-109 / Seres Therap
Efficacy and safety of SER-109, an investigational microbiome therapeutic for recurrent clostridioides difficile infection: Data from ECOSPOR III, a phase 3 randomized trial. (Available On Demand; 357) - Apr 28, 2022 - Abstract #ASCO2022ASCO_919;
P3
After standard-of-care antibiotics (vancomycin or fidaxomicin per investigator discretion), subjects were randomized 1:1 to SER-109 (4 capsules x 3 days) or matching placebo. In this population of subjects with comorbidities, including malignancy and immunosuppression, SER-109 significantly reduced rCDI rates through week 24 with an observed safety profile comparable to placebo.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Molecular dissection of RbpA-mediated regulation of fidaxomicin sensitivity in mycobacteria. (Pubmed Central) - Apr 27, 2022
In support of the association between RP stability and Fdx activity, we find that another factor that promotes RP stability in bacteria, CarD, also impacts to Fdx sensitivity. Our findings highlight how RbpA and other factors may influence RNAP dynamics to affect Fdx sensitivity.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal, HEOR: Health-related quality of life in patients with recurrent Clostridioides difficile infections. (Pubmed Central) - Apr 26, 2022
P2, P3
The RCT was preregistered at EudraCT (j.no. 2015-003004-24, https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-003004-24/results) and at ClinicalTrials.gov (study identifier NCT02743234, https://clinicaltrials.gov/ct2/show/NCT02743234).
- Dificid (fidaxomicin) / Merck (MSD), Astellas
REAL-WORLD COMPARATIVE EFFECTIVENESS OF FIDAXOMICIN VS. VANCOMYCIN AMONG MEDICARE BENEFICIARIES WITH CLOSTRIDIOIDES DIFFICILE INFECTION (11 - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_4109;
Strikingly, the absolute differences in the clinical outcomes observed in our real-world study were quite similar to those reported in the fidaxomicin randomized trials. Our findings support the 2021 change in clinical guidelines recommending fidaxomicin over vancomycin.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
PRE-FMT ANTIBIOTIC USE IS ASSOCIATED WITH HIGHER RATES OF CURE AFTER FECAL MICROBIOTA TRANSPLANTATION FOR RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION (Poster Hall - San Diego Convention Center) - Apr 25, 2022 - Abstract #DDW2022DDW_2958;
There were no differences between vancomycin or fidaxomicin pre-FMT on CDI outcome. This suggests that use of antibiotics pre-FMT may facilitate success, but further studies are needed to determine an adequate washout of antibiotics pre-FMT.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Basis of narrow-spectrum activity of fidaxomicin on Clostridioides difficile. (Pubmed Central) - Apr 23, 2022
By combining structural, biochemical, genetic and bioinformatic analyses, we establish that a single residue in Cdiff RNA polymerase is a sensitizing element for fidaxomicin narrow-spectrum activity. Our results provide a blueprint for targeted drug design against an important human pathogen.
- || vancomycin / Generic mfg.
Retrospective data, Review, Journal: Systematic Review and meta-analysis: efficacy of vancomycin taper and pulse regimens in clostridioides difficile infection. (Pubmed Central) - Apr 22, 2022
Vancomycin taper-and-pulse seems superior to pulse alone or taper alone for recurrent CDI. A randomized controlled trial comparing vancomycin taper-and-pulse to fidaxomicin and microbiome restoration is needed.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas, Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Clinical, Journal: Genetically related Clostridium difficile from water sources and human CDI cases revealed by whole-genome sequencing. (Pubmed Central) - Apr 9, 2022
Resistance to vancomycin, clindamycin, erythromycin and meropenem was detected in 5.3% (4/76), 26.3% (20/76), 1.3% (1/76) and 6.6% (5/76) of isolates, respectively...Overall, 19.2% (5/26) of human strains shared a recent genomic relationship with one or more water strains. This study supports the growing hypothesis that environmental contamination by C. difficile plays a role in CDI transmission.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
How the antibiotic fidaxomicin targets an intestinal pathogen https://t.co/kAPTaBQDxt (Twitter) - Apr 6, 2022
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Trial completion, Enrollment change: Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection (clinicaltrials.gov) - Apr 4, 2022
P2, N=4, Completed, Sponsor: University of Alberta
This study supports the growing hypothesis that environmental contamination by C. difficile plays a role in CDI transmission. Recruiting --> Completed | N=30 --> 4
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: The Risk of Clostridioides difficile Recurrence after Initial Treatment with Vancomycin or Fidaxomicin Utilizing Cerner Health Facts. (Pubmed Central) - Mar 26, 2022
(3) A statistically significantly lower risk of CDI recurrence was observed with fidaxomicin use in the matched cohort (889 patients per treatment) using a Cox Proportional Hazards model (HR 0.67, 95% CI 0.50-0.90). (4) Fidaxomicin was independently associated with a decreased CDI recurrence, as defined by readmission for CDI within 90 days.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Impact of Oral Metronidazole, Vancomycin, and Fidaxomicin on Host Shedding and Environmental Contamination with Clostridioides difficile. (Pubmed Central) - Mar 15, 2022
P4
Fidaxomicin, and to a lesser extent vancomycin, reduces C. difficile shedding and contamination of the hospital environment relative to metronidazole. Treatment choice may play a role in reducing healthcare-associated C. difficile transmission.
- | irinotecan / Generic mfg.
Journal: Delayed Diagnosis of Clostridium difficile Colitis in a 48-Year-Old Woman with a Homozygous Mutation of the UGT1A1 Gene While on Chemotherapy for Colorectal Carcinoma. (Pubmed Central) - Mar 8, 2022
CONCLUSIONS This report has shown that in complex cases where patients are treated with chemotherapy and have increased susceptibility to drug toxicity, chronic diarrhea may still have an infectious cause. Only when the diagnosis is correctly made can the patient be appropriately treated.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
New P3 trial: FENDER: Fecal Microbiota Transplantation in Clostridioides Difficile Infection First Episode and First Recurrence (clinicaltrials.gov) - Mar 4, 2022
P3, N=220, Not yet recruiting, Sponsor: Benoit Guery
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Trial completion date, Trial termination, Trial primary completion date: Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection (clinicaltrials.gov) - Feb 25, 2022
P3, N=50, Terminated, Sponsor: McMaster University
Only when the diagnosis is correctly made can the patient be appropriately treated. Trial completion date: Jun 2022 --> Aug 2021 | Recruiting --> Terminated | Trial primary completion date: Dec 2021 --> Aug 2021; Insufficient resource to complete the study
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Diversity of Circulating Clostridioides difficile Ribotypes in Mexico and Susceptibility to Fidaxomicin, Vancomycin, and Metronidazole. (Pubmed Central) - Feb 23, 2022
No isolates with reduced susceptibility to fidaxomicin were found; however, 38 (33.04%) isolates had reduced susceptibility to metronidazole, and 7 isolates (6.1%) had reduced susceptibility to vancomycin. These findings highlight the need for continuous surveillance of C. difficile RTs and antimicrobial susceptibility testing.
- | Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Molecular Characterization of, and Antimicrobial Resistance in, Clostridioides difficile from Thailand, 2017-2018. (Pubmed Central) - Feb 17, 2022
Point substitutions in the penicillin-binding proteins were not sufficient to confer meropenem resistance, but a Y721S substitution in PBP3 was associated with a 4.37-fold increase in meropenem minimal inhibitory concentration. No resistance to metronidazole, vancomycin, or fidaxomicin was observed.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Journal: The need for a holistic view on management of Clostridioides difficile infection. (Pubmed Central) - Feb 10, 2022
No resistance to metronidazole, vancomycin, or fidaxomicin was observed. No abstract available
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: This is one of the cases should get Fidaxomicin in 1st episode. I would not risk it with po vanco especially with severe reaction DRESS. (Twitter) - Feb 9, 2022
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Review: Metronidazole is a poor choice. Review the guidelines. The question can be rephrased as which one would you want for yourself? Fidaxomicin for me. (Twitter) - Feb 9, 2022
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Fidaxomicin for sure. Was it treated with DAIR or resection? (Twitter) - Feb 9, 2022
- || vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Why not metronidazole? Fidaxomicin would be my choice for recurrence, but not for the first episode. I think metronidazol is still worth a try. Wouldn‘t dare to give vancomycin as this is asking for trouble 😵💫 (Twitter) - Feb 9, 2022
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Oooh spicy question! I voted wrong but yes, vanco definitely gets absorbed. As a fellow, team got a vanco serum level for unclear reasons and it was very detectable! This may be the one time I reluctantly prescribe Fidaxomicin (Twitter) - Feb 8, 2022
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Argh I missed clicking fidaxomicin. Not worth any risk when an alternative exists. (Twitter) - Feb 8, 2022
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Absorption is poor ≠ Absorption is zero. Will avoid esp p.o vanc if has had severe reaction like DRESS with IV. Break the bank for fidaxomicin on this one. (Twitter) - Feb 8, 2022
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: In fact in Quebec I believe for a long time this was (and possibly still is?) the only legitimate factor where fidaxomicin is covered for non hospitalized patients! (Twitter) - Feb 8, 2022
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Had this exact scenario (different prior infection requiring abx) when I was a fellow. Only difference was they were failing metronidazole at the time. Went with fidaxomicin and they did well. There is some marginal amount of vanc absorption orally, it's not zero. (Twitter) - Feb 8, 2022
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: Would favor fidaxomicin… especially if risk factors present which could increase systemic absorption of PO vanco. (Twitter) - Feb 8, 2022