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


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  • ||||||||||  Flagyl (metronidazole) / SLA
    Review, Journal:  Management of Clostridioides difficile colitis: insights for the gastroenterologist. (Pubmed Central) -  May 21, 2019   
    Several other therapies are undergoing clinical trials. This narrative review focuses on the treatment of CDI with a summary of literature on the newer modalities and the treatment guidelines issued by Infectious Diseases Society of America and European Society of Clinical Microbiology and Infectious Diseases.
  • ||||||||||  meropenem / generics
    Journal:  Prevalence and antimicrobial susceptibility pattern of toxigenic Clostridium difficilestrains isolated in Iran (Pubmed Central) -  May 14, 2019   
    In E-test method, all C. difficile isolates were susceptible to fidaxomicin, vancomycin, amoxicillin/clavulanate, and meropenem and were resistant to penicillin G. The prevalence of multidrug resistant C. difficile was 69.33% (373/538). Among 538 C. difficile, 147 (27.32%), 169 (31.41%), and 222 (41.26%) isolates were TcdA+/TcdB+, TcdA-/TcdB+, and TcdA-/TcdB-, respectively The results evidently support the hypothesis of a probable role of toxigenic strains of C. difficile in developing gastrointestinal complaints in patients with diarrhea
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  Discovery, properties, and biosynthesis of pseudouridimycin, an antibacterial nucleoside-analog inhibitor of bacterial RNA polymerase. (Pubmed Central) -  May 8, 2019   
    Pseudouridimycin (PUM) is a novel pseudouridine-containing peptidyl-nucleoside antibiotic that inhibits bacterial RNA polymerase (RNAP) through a binding site and mechanism different from those of clinically approved RNAP inhibitors of the rifamycin and lipiarmycin (fidaxomicin) classes...We also describe the RNAP-inhibitory and antibacterial properties of PUM. Finally, we review available information on the gene cluster and pathway for PUM biosynthesis and on the potential for discovering additional novel pseudouridine-containing nucleoside antibiotics by searching bacterial genome and metagenome sequences for sequences similar to pumJ, the pseudouridine-synthase gene of the PUM biosynthesis gene cluster.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Clinical, Review, Journal:  Management of adult Clostridium difficile digestive contaminations: a literature review. (Pubmed Central) -  May 7, 2019   
    Innovative therapies such as fecal microbiota transplantation (FMT) and antitoxin antibodies were developed to limit the occurrence of recurrence of CDI. Research is therefore very active, and new antibiotics are being studied as surotomycin, cadazolid, and rinidazole.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, surotomycin (MK-4261) / Merck (MSD), cadazolid (ACT-179811) / J&J
    Review, Journal:  Emerging drugs for the treatment of Clostridium difficile. (Pubmed Central) -  Apr 26, 2019   
    Furthermore, in recent years several new antibiotics with narrow-spectrum activity and low intestinal resorption have been developed, including surotomycin, cadazolid, and ridinilazol, and novel toxoid vaccines are expected to be efficacious in the prevention of C. difficile infection...Expert opinion We have today a wide spectrum of promising therapeutic possibilities against infection. Pivotal future clinical trials may be crucial in developing effective strategies to optimize outcomes, mainly in high-risk population.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Preclinical, Journal:  andactivities of DS-2969b, a novel GyrB inhibitor, against. (Pubmed Central) -  Apr 21, 2019   
    DS-2969b showed similar fecal excretion after intravenous and oral administrations in rats. These data support further development of DS-2969b as a drug for oral and intravenous treatment of CDI.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  A scoring system for prescribing fidaxomicin in Clostridium diffícile infection (Pubmed Central) -  Apr 11, 2019   
    Despite this superiority, its high cost has led to very restrictive policies in its use, as such that many institutions only use it in patients with multiple recurrences. While waiting for new predictive clinical tools, we propose the development of scoring systems that allow the more high-risk patients to be treated earlier.
  • ||||||||||  Flagyl (metronidazole) / SLA
    Journal:  Clostridium difficile remains a medical challenge (Pubmed Central) -  Apr 10, 2019   
    Fecal bacteriotherapy is recommended in treatment and prevention of recurrent CDI. Surgery is indicated in progressive complicated forms when no response to medication is achieved and the patient is in a critical condition.Key words: Clostridium difficile intestinal infection epidemic ribotypes clostridium colitis treatment.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Clostridioides difficile trehalose metabolism variants are common and not associated with adverse patient outcomes (HALL B) -  Apr 5, 2019 - Abstract #ECCMID2019ECCMID_3688;    
    Trehalose metabolism variants are widespread in multiple distinct C. difficile genotypes, which suggests that this phenotype has not conferred a unique selective advantage to support the rise of ribotypes 027 and 078. Additionally, we find that the presence of the trehalose four-gene cluster is not associated with mortality in CDIs due to a commonly circulating C. difficile lineage.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    The effect of using fidaxomicin on recurrent Clostridium difficile infection? () -  Apr 5, 2019 - Abstract #ECCMID2019ECCMID_354;    
    Our results indicate fidaxomicin is best suited as a first line treatment for mild CDI rather than current UK guidance suggesting its use for severe or rCDI. In the patient group where multiple episodes of CDI are seen, we propose using FMT as treatment for rCDI.
  • ||||||||||  Flagyl (metronidazole) / SLA, Avelox (moxifloxacin) / Bayer
    Journal:  Antimicrobial resistance in large clostridial toxin-negative, binary toxin-positive Clostridium difficile ribotypes. (Pubmed Central) -  Mar 25, 2019   
    ...All strains were susceptible to vancomycin, metronidazole and fidaxomicin, antimicrobials currently considered first-line treatments for C. difficile infection (CDI)...Phenotypic resistance was observed in 13 isolates to tetracycline (TetR, MIC = 16 mg/L), moxifloxacin (MxfR, MIC = 16 mg/L), erythromycin (EryR, MIC ≥128 mg/L) and clindamycin (CliR, MIC = 8 mg/L)...This work describes the presence of multiple AMR genes in ABCDTC. difficile strains and provides the first comprehensive analysis of the AMR repertoire in these lineages isolated from human, animal, food and environmental sources.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, NN1213 / Novo Nordisk
    Enrollment closed:  FACIT: Fecal Microbiota Transplantation for Relapsing Clostridium Difficile Infection (clinicaltrials.gov) -  Oct 24, 2018   
    P3,  N=64, Active, not recruiting, 
    The findings of this study suggest that oral vancomycin and fidaxomicin are comparable options for CDI treatment in allogeneic SCT patients within 100 days following transplant. Recruiting --> Active, not recruiting
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Trial primary completion date:  OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) -  Dec 8, 2017   
    P4,  N=546, Recruiting, 
    Initiation date: Oct 2017 --> Feb 2018 Trial primary completion date: Dec 2017 --> May 2022
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Trial completion, Trial initiation date:  C-Diff: Impact of Oral Antibiotic Treatment on C. Difficile (clinicaltrials.gov) -  Nov 6, 2017   
    P=N/A,  N=30, Completed, 
    This series demonstrates that FMT is a highly effective and safe therapeutic option for multiply recurrent CDI in patients with cancer treated with cytotoxic chemotherapy. Recruiting --> Completed | Initiation date: Feb 2014 --> Jun 2014
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Enrollment closed, Trial primary completion date:  Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection (clinicaltrials.gov) -  Sep 13, 2017   
    P3,  N=50, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial primary completion date: Dec 2016 --> Aug 2016 Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2016 --> Dec 2017
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Trial primary completion date:  OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) -  Jul 19, 2017   
    P4,  N=546, Recruiting, 
    Recruiting --> Active, not recruiting Trial primary completion date: Jun 2017 --> Dec 2017
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Review, Journal:  Diagnosis and treatment of Clostridium difficile (C. diff) colitis: Review of the literature and a perspective in gynecologic oncology. (Pubmed Central) -  May 27, 2017   
    Rectal vancomycin may play an adjunctive role for some severe cases, while surgical intervention is indicated for fulminant CDI if no improvement six or more days after initiating medical therapy. For non-severe recurrent disease, the initial treatment regimen should be repeated, while subsequent episodes are more appropriately treated with a tapered and pulsed dose of vancomycin, fidaxomicin, or fecal microbiota transplantation.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Enrollment closed, Enrollment change:  Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile? (clinicaltrials.gov) -  May 9, 2017   
    P=N/A,  N=203, Active, not recruiting, 
    For non-severe recurrent disease, the initial treatment regimen should be repeated, while subsequent episodes are more appropriately treated with a tapered and pulsed dose of vancomycin, fidaxomicin, or fecal microbiota transplantation. Recruiting --> Active, not recruiting | N=100 --> 203
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Phase classification, Trial primary completion date:  C-Diff: Impact of Oral Antibiotic Treatment on C. Difficile (clinicaltrials.gov) -  May 2, 2017   
    P=N/A,  N=30, Recruiting, 
    Recruiting --> Active, not recruiting | N=100 --> 203 Phase classification: P4 --> P=N/A | Trial primary completion date: Mar 2017 --> Aug 2017
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Trial completion:  OPT-80 in Clostridium Difficile-Associated Diarrhea (CDAD) (clinicaltrials.gov) -  Mar 26, 2017   
    P2,  N=0, Completed, 
    Trial primary completion date: Jun 2017 --> Dec 2017 No longer recruiting --> Completed
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Trial primary completion date:  OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) -  Dec 20, 2016   
    P4,  N=546, Recruiting, 
    Active, not recruiting --> Recruiting Trial primary completion date: Dec 2016 --> Jun 2017