Dificid (fidaxomicin) / Merck (MSD), Astellas 
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 11 Diseases   2 Trials   2 Trials   1352 News 


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  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Review, Journal:  Treatment of Severe and Fulminnant Clostridioides difficile Infection. (Pubmed Central) -  Nov 21, 2019   
    A patient population likely to benefit the most from FMT is elderly patients due to their increased risk for CDI, treatment failure, and high comorbidity burden that may preclude surgical intervention. FMT should be considered in patients with SCDI or FCDI particularly when traditional anti-CDI antibiotics are ineffective.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Preclinical, Journal:  Novel In Vitro Method Reveals Drugs that Inhibit Solute Transporter Alpha/Beta (OSTα/β). (Pubmed Central) -  Nov 21, 2019   
    This study utilized a novel in vitro method to identify OSTα/β inhibitors, and for the first time, provided IC50 values for OSTα/β inhibition. These data provide evidence that several drugs, some of which are associated with cholestatic drug-induced liver injury, may impair the function of the OSTα/β transporter.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Review, Journal:  Clostridium difficile infection: review. (Pubmed Central) -  Nov 19, 2019   
    Antibiotics of choice are vancomycin, fidaxomicin, and metronidazole, though metronidazole is considered as inferior. The goal of this review is to update physicians on current scientific knowledge of C. difficile infection, focusing also on fecal microbiota transplantation which is a promising therapy.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Reconstruction of Human AML Reveals Stem Cell Origin and Therapeutic Targets for Treatment Resistant CD34-/Lo MLL-Rearranged Leukemia (Hall B, Level 2 (Orange County Convention Center)) -  Nov 7, 2019 - Abstract #ASH2019ASH_4399;    
    Strikingly, shRNA-mediated knockdown or pharmacological inhibition by fidaxomicin targeting ATP-binding cassette (ABC) transporters, ABCC3 that is highly expressed in HSCs-derived MLL-AML could re-sensitize the cells to the current chemotherapy . Together, the current study not only for the first time functionally identifies the origin of human MLL-AML stem cells, but also provides a new actionable venue for overcoming stem cells-associated treatment resistance by repositioning an anti-diarrhea drug, fidaxomicin currently available in the clinics.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, warfarin / Generic Mfg., Eliquis (apixaban) / BMS
    Clinical, Review, Journal:  Hospital Medicine Update: High-Impact Literature from March 2018 to April 2019. (Pubmed Central) -  Oct 22, 2019   
    The authors voted to select 10 of 30 presented articles based on quality and clinical impact for this summary. The key findings include: (1) Vancomycin or fidaxomicin are the first-line treatment for initial Clostridioides difficile infection; (2) Unnecessary supplemental oxygen is linked to increased mortality; aim for a target oxygen saturation of 90%-94% in most hospitalized patients; (3) Stigmatizing language in medical records impacts physician trainees' attitudes and pain management practices; (4) Consider ablation for atrial fibrillation in patients with heart failure; (5) Patients with opioid use disorder should be offered buprenorphine or methadone therapy; (6) Apixaban is safe and may be preferable over warfarin in patients with atrial fibrillation and end-stage kidney disease; (7) It is probably safe to discontinue antimethicillin-resistant Staphylococcus aureus (MRSA) coverage in patients with hospital-acquired pneumonia who are improving and have negative cultures; (8) Selected patients with left-sided endocarditis (excluding MRSA) may switch from intravenous (IV) to oral antibiotics if they are clinically stable after 10 days; (9) Oral antibiotics may be equivalent to IV antibiotics in patients with joint and soft tissue infections; (10) A history-electrocardiogram-age-risk factors-troponin (HEART) score ≥4 is a reliable threshold for determining the patients who are at risk for short-term major adverse cardiac events and may warrant further evaluation.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, NN1213 / Novo Nordisk
    Trial completion, Trial completion date, Trial primary completion date:  FACIT: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (clinicaltrials.gov) -  Oct 15, 2019   
    P3,  N=64, Completed, 
    Incidence of TEAEs was similar to previous Phase III trials, suggesting that fidaxomicin is comparatively well tolerated in patients with IBD. Active, not recruiting --> Completed | Trial completion date: Apr 2019 --> Aug 2019 | Trial primary completion date: Aug 2018 --> Feb 2019
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Phase classification:  C-Diff: Impact of Oral Antibiotic Treatment on C. Difficile (clinicaltrials.gov) -  Oct 2, 2019   
    P4,  N=33, Completed, 
    Active, not recruiting --> Completed | Trial completion date: Apr 2019 --> Aug 2019 | Trial primary completion date: Aug 2018 --> Feb 2019 Phase classification: P=N/A --> P4
  • ||||||||||  Flagyl (metronidazole) / SLA
    Review, Journal:  Treatment of acute and recurrent Clostridium difficile infections : What is new? (Pubmed Central) -  Sep 14, 2019   
    In recent years, several new antibiotics with narrow-spectrum acitivity and low intestinal resorption have been developed for the treatment of CDI, including surotomycin, cadazolid, and ridinilazol. Novel toxoid vaccines are expected to become an efficacious tool in the prevention of CDI; however, pivotal clinical trials have so far not been completed.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    First-line Fidaxomicin Use in High Risk Inpatients Reduces Recurrence Rates () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2843;    
    Global cure and CDI upon readmission also improved in the post-group (Table 1). In patients receiving partial courses of fidaxomicin, recurrence (9.3% vs 25%, P=0.19), global cure (86% vs 75%, P=0.44), and infection on readmission (28.6% vs 37.5%, P=0.67) were similar.Conclusion : Fidaxomicin as a first line agent in high risk CDI patients decreased recurrence and increased global cure.
  • ||||||||||  vancomycin / generics
    One Dose Vancomycin Prophylaxis for In-Hospital Clostridioides difficile - Associated Disease () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2829;    
    Recent reports suggest that prophylactic administration of vancomycin or fidaxomicin might reduce in-hospital CDAD incidence...OVP group received ≥ 1 dose of vancomycin 125 mg once per day.Results : Patients within OVP group (122; 25.2%) had higher age adjusted Charlson comorbidity index (CCI) (8; IQR 6-10 vs. 6; 5-8), were more often hospitalized within 3 months (62; 50.8% vs. 121; 33.4%), more commonly received piperacillin/tazobactam (60; 49.2% vs. 81; 22.4%) and carbapenems (27; 22.1% vs. 43; 11.9%) with longer duration of antibiotic therapy (14; 10-20 vs 10; 10-14 days)...Only CDAD during index hospitalization was associated with 90-day readmission (HR 4.60; 95%CI 1.93-10.96).Conclusion : Primary OVP was highly effective in reducing the risk of in-hospital CDAD in elderly patients treated with systemic antimicrobial therapy. Prospective studies with follow-up are needed to define long-term efficacy and potential risks of this strategy. 
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Incidence of Clostridioides Difficile Infection Among United States Medicare Advantage Enrollees () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2799;    
    CDI patients were more likely than non-CDI patients to be older (mean age, 78.3 vs 76.1 y, P < 0.0001), be women (64.5% vs 58.1%, P < 0.0001), or have comorbidities (mean Charlson comorbidity index score, 4.5 vs 1.8, P < 0.0001).Conclusion : CDI incidence rates in the Medicare Advantage population were similar to those reported previously in the Medicare fee-for-service population and nationally among adults aged ≥ 65 years. Data are consistent with a high CDI burden among older US adults.Funding: Pfizer
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Impact of Two-Step Testing on the Diagnosis and Management of Clostridium difficile in a Multi-Hospital Healthcare System () -  Aug 26, 2019 - Abstract #IDWeek2019IDWeek_2403;    
    Anti-CDI agents included fidaxomicin, metronidazole and oral vancomycin, but may have included non-CDI indications for metronidazole.Results : A total of 115 HO-CDI cases were identified; 91 (79%) before and 24 (21%) after. Use of a two-step approach for CDI testing reduced HO-CDI rates, but did not have a significant impact on anti-CDI antibiotic use in a multi-hospital community health system.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
    FMT in clinical practice for C. difficile infection: Pro (F3) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_108;    
    Donors are also included in the folllow-up to recognise diseases of which transmission to donors could be possible. In summary, FMT will remain as the first treatment choice for patients with rCDI, unless new regulations will classify donor feces suspensions as a drug or pharmaceutical product.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  Tiacumicin Congeners with Improved Antibacterial Activity from a Halogenase-Inactivated Mutant. (Pubmed Central) -  Aug 17, 2019   
    Tiacumicin B (1, also known as fidaxomicin or difimicin) is a marketed drug for the treatment of Clostridium difficile infections...Herein we report the isolation, structure elucidation, and bioactivity evaluation of 14 tiacumicin congeners (including 11 new ones) from the tiaM-inactivated mutant. A new tiacumicin congener, 3, with a propyl group at C-7‴ of the aromatic ring was found to exhibit improved antibacterial activity.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  The effect of using Fidaxomicin on recurrent Clostridium difficile infection? (Pubmed Central) -  Aug 15, 2019   
    There were mixed results with using fidaxomicin for severe CDI, with only 42% of patients responding. Our results suggest fidaxomicin is best suited as a treatment for mild CDI during a patient's first episode.
  • ||||||||||  Flagyl (metronidazole) / SLA, ceftriaxone / Generic Mfg.
    Treatment of Severe Clostridioides difficile Infection With Intravenous Immunoglobulin (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1578;    
    Her hospital course was long and complicated, requiring trials of multiple antibiotics: ceftriaxone, metronidazole, piperacillin-tazobactam, and ertapenem...Despite 5 days of oral vancomycin, symptoms did not regress...Fidaxomicin was started...Moreover, IVIG may prove to be cost-effective by preventing severe or recurrent disease. In cases of CDI refractory to standard antibiotic treatment, passive immunity with IVIG may be a reasonable adjunct to standard therapy.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Failed Fecal Microbiota Transplantation for Fulminant C. difficile Colitis With Toxic Megacolon (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1517;    
    The mechanism of benefit may be multifactorial, including repopulation of normal colonic flora and mechanical colonic decompression. Although our patient died, her case provides a framework for clinicians to consider this therapy and the expected response.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Clostridioides difficile Enteritis Refractory to Multiple Fecal Microbiota Transplantions (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1312;    
    Over the next year, she had multiple recurrences of her CDI that failed vancomycin, fidaxomicin and IV immunoglobulin (IVIG)...Oral metronidazole has been used, with oral vancomycin used for refractory cases...Our case is unusual given the ongoing symptoms in a PCR negative CDI state. Further research is needed in patients with refractory CDI enteritis with analysis of their bowel flora to better understand this disease and how to treat it
  • ||||||||||  Remicade (infliximab) / Mitsubishi Tanabe, J&J, Xeljanz (tofacitinib) / Pfizer
    Refractory Fulminant Ulcerative Colitis With Concurrent Clostridioides difficile Colitis Challenging Modern Guideline-Directed Medical Therapy to Failure (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1010;    
    He had IBD-related arthritis & was started on sulfasalazine then methotrexate (MTX)...Despite IV steroids, infliximab, & tofacitinib; sulfasalazine & MTX; parallel PO vancomycin, fidaxomicin, IVIG & FMT, along with lactobacillus acidophilus, bloody diarrhea continued; patient was dependent on fluid support & blood transfusions...Safety & efficacy of the various treatments including immunosuppressants & FMT in cases of concurrent UC & CDI is a grey zone. Further case-reports & studies are needed to establish the optimal stepwise approach & guide therapeutic choice & decision making.