Dificid (fidaxomicin) / Merck (MSD), Astellas 
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 11 Diseases   2 Trials   2 Trials   1263 News 


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  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Review, Journal:  Clostridioides difficile Infection, Still a Long Way to Go. (Pubmed Central) -  Jan 28, 2021   
    However, the management of CDI recurrences and severe infections remain challenging and the main question remains: how to best target these often expensive treatments to the right population. In this review we discuss current diagnostic approaches, treatment and potential prevention strategies, with a special focus on recent advances in the field as well as areas of uncertainty and unmet needs and how to address them.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Enrollment open:  Evaluation of Fidaxomicin in the Treatment of Clostridium Difficile Infection (CDI) (clinicaltrials.gov) -  Jan 15, 2021   
    P=N/A,  N=50, Enrolling by invitation, 
    Some data point to the efficacy of oral vancomycin prophylaxis in patients who reccur CDI when systemic antibiotics are required again. Active, not recruiting --> Enrolling by invitation
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  Total Synthesis of Tiacumicin B: Study of the Challenging β-Selective Glycosylations. (Pubmed Central) -  Jan 13, 2021   
    Ring-size selective Shiina macrolactonization provided a semi-glycosylated aglycone that was engaged directly in the noviolysation step with a virtually total β-selectivity. Finally, a novel deprotection method was devised for the removal of a 2-naphthylmethyl (Nap) ether on a phenol and efficient removal of all the protecting groups provided synthetic tiacumicin B.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Clinical, Journal:  Epidemiologic trends in Clostridioides difficile isolate ribotypes in United States from 2011 to 2016. (Pubmed Central) -  Jan 13, 2021   
    Each of the geographical areas had variations which differed from each other, but collectively, these results suggest that the changing epidemiology of C. difficile in the US is consistent with what is being seen in Europe. Continued surveillance and monitoring of changes in ribotype distributions of C. difficile are warranted.
  • ||||||||||  Journal:  Diagnostic and therapy of severe Clostridioides difficile infections in the ICU. (Pubmed Central) -  Jan 12, 2021   
    Several reports suggest that fecal microbiota transplantation could be discussed, as it is well tolerated and associated with a high rate of clinical cure. CDI is a dynamic and active area of research with new diagnostic techniques, molecules, and management concepts likely changing our approach to this old disease in the near future.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    [VIRTUAL] Evaluation of fidaxomicin use at an academic medical center () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_3249;    
    The majority of patients (82.1%) treated for a recurrent infection received previous treatment with oral vancomycin. This study suggests that the use of fidaxomicin at our academic medical center correlated with a higher frequency of having an infectious disease consult, being on a medical floor, use to treat a recurrent C. difficile infection, and ATLAS severity score of 1-4 on admission.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Journal:  Treatment of Clostridioides (Clostridium) difficile infection. (Pubmed Central) -  Dec 23, 2020   
    Key messages:The cornerstones for the treatment of CDI are vancomycin and fidaxomicin. Metronidazole should be used only in mild-to-moderate disease in younger patients who have no or only few risk factors for recurrence.In recurrent CDI, bezlotoxumab infusion (a monoclonal antibody against C. difficile toxin B) may be considered as an adjunctive therapeutic strategy in addition to the standard care provided to patients with several risk factors for recurrence.Fecal microbiota transplantation (FMT) should be offered to patients with frequently recurring CDI.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Review, Journal:  Clostridioides difficile infection evaluation and management in the emergency department. (Pubmed Central) -  Dec 22, 2020   
    Metronidazole should be used only in mild-to-moderate disease in younger patients who have no or only few risk factors for recurrence.In recurrent CDI, bezlotoxumab infusion (a monoclonal antibody against C. difficile toxin B) may be considered as an adjunctive therapeutic strategy in addition to the standard care provided to patients with several risk factors for recurrence.Fecal microbiota transplantation (FMT) should be offered to patients with frequently recurring CDI. CDI cause significant illness throughout the U.S. Successful CDI diagnosis and management in the ED require current knowledge of risk, presentation, diagnosis, and proper antibiotic treatment.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Clinical, Journal:  Risk Factors and Outcome of C. difficile Infection after Hematopoietic Stem Cell Transplantation. (Pubmed Central) -  Nov 21, 2020   
    Patients with a history of previous abdominal surgery or HCV infection, or those who had received broad spectrum parenteral antibacterial therapy were at major risk for CDI development. CDIs were successfully treated with vancomycin or fidaxomicin after auto-HSCT as well as after allo-HSCT.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  A convergent approach toward fidaxomicin: Syntheses of the fully glycosylated northern and southern fragments. (Pubmed Central) -  Nov 18, 2020   
    We developed a robust approach to each of the key macrocyclic and sugar fragments, their union via stereoselective glycosylation, and a convergent late-stage macrolide formation with fully glycosylated fragments. Although we were able to demonstrate that the final Suzuki cross-coupling and ring-closing metathesis steps enabled macrocycle formation in the presence of the northern resorcylic rhamnoside and southern novioside sugars, these final steps were hampered by poor yields and the formation of the unwanted Z-macrocycle as the major stereoisomer.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Preclinical, Journal:  The gut microbiome diversity of Clostridioides difficile-inoculated mice treated with vancomycin and fidaxomicin. (Pubmed Central) -  Nov 12, 2020   
    Although we were able to demonstrate that the final Suzuki cross-coupling and ring-closing metathesis steps enabled macrocycle formation in the presence of the northern resorcylic rhamnoside and southern novioside sugars, these final steps were hampered by poor yields and the formation of the unwanted Z-macrocycle as the major stereoisomer. Both C. difficile inoculation and treatment with vancomycin or fidaxomicin reduced microbiota diversity; however, dysbiosis associated with fidaxomicin was milder than with vancomycin.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  Clostridium difficile Infection: an update on treatment and prevention. (Pubmed Central) -  Nov 12, 2020   
    A diligent analysis of risk factors and knowledge of pathogenesis are a prerequisite to practical implementation of effective and rational precautions to curb spreading of this illness. In the future, we anticipate increased use of fecal microbiota transplant, improvements in faecal transplant administration, wider use of probiotics and selective ATBs and further introduction of passive and active immunization into practice.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, NN1213 / Novo Nordisk
    Enrollment open:  OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) -  Nov 10, 2020   
    P4,  N=549, Recruiting, 
    In the future, we anticipate increased use of fecal microbiota transplant, improvements in faecal transplant administration, wider use of probiotics and selective ATBs and further introduction of passive and active immunization into practice. Active, not recruiting --> Recruiting
  • ||||||||||  Review, Journal:  Investigational Treatment Agents for Recurrent Clostridioides difficile Infection (rCDI). (Pubmed Central) -  Nov 1, 2020   
    Various emerging potential therapies with narrow spectrum of activity and little systemic absorption that are in development include 1) Ibezapolstat (formerly ACX-362E), MGB-BP-3, and DS-2969b-targeting bacterial DNA replication, 2) CRS3213 (REP3123)-inhibiting toxin production and spore formation, 3) ramizol and ramoplanin-affecting bacterial cell wall, 4) LFF-571-blocking protein synthesis, 5) Alanyl-L-Glutamine (alanylglutamine)-inhibiting damage caused by C. difficile by protecting intestinal mucosa, and 6) DNV3837 (MCB3681)-prodrug consisting of an oxazolidinone-quinolone combination that converts to the active form DNV3681 that has activity in vitro against C. difficile. This review article provides an overview of these developing drugs that can have potential role in the treatment of rCDI and in lowering recurrence rates.