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


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  • ||||||||||  Zinplava (bezlotoxumab) / Merck (MSD)
    Bezlotoxumab As Treatment for Recurrent/Chronic Clostridioides Difficile Infection in Stem Cell Transplant Recipients () -  Dec 7, 2024 - Abstract #ASH2024ASH_9439;    
    The patient's post-SCT course was complicated by Streptococcus mitis/oralisbacteremia, resulting in a long course of broad-spectrum antibiotics with vancomycin and meropenem...At this recurrence, she was hospitalized for dehydration and treated with oral vancomycin, subsequently transitioning to oral fidaxomicin over a 21-day taper...All patients were confirmed to have no gastrointestinal GVHD causing the diarrhea, and no recurrence of diarrhea occurred after bezlotoxumab. This case series strongly suggests the potential utility of bezlotoxumab for treating rCDI in the pediatric SCT patient population.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  Switching Residues: A Platform for the Synthesis of Fidaxomicin Antibiotics. (Pubmed Central) -  Nov 25, 2024   
    We combined the allylic substitution with an organocatalysed novioside acylation protocol to enable the functionalisation of two vectors on Fdx in one pot. This platform greatly expands the accessible chemical space for Fdx derivatives and enables the future development of systemic Fdx antibiotics.
  • ||||||||||  ibezapolstat (ACX-362E) / Acurx Pharma
    Preclinical, Journal:  Microbiome impact of ibezapolstat and other Clostridioides difficile infection relevant antibiotics using humanized mice. (Pubmed Central) -  Nov 22, 2024   
    Previous studies demonstrated IBZ carries a favorable microbiome diversity profile compared to vancomycin (VAN)...Groups of germ-free (GF) mice received a fecal microbiota transplant from one of two healthy human donors and were subsequently exposed to either IBZ, VAN, fidaxomicin (FDX), metronidazole (MET), or no antibiotic (control)...In microbiome-humanized mice, IBZ and FDX had smaller effects on gut microbiome diversity compared to VAN and MET. Notable differences were observed between the microbiome of IBZ- and FDX-treated groups, which may allow for differentiation of these two antibiotics in future studies.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
    Journal:  Microbiota restoration for recurrent Clostridioides difficile infection. (Pubmed Central) -  Oct 9, 2024   
    Broad spectrum antibiotics such as vancomycin leads to further disruption of microbiota compared to fidaxomicin which has a lower disruption of the microbiota and leads to fewer recurrences...Intravenous bezlotoxumab is a monoclonal antibody that reduces the risk of recurrence in high-risk patients but does not restore the microbiota...Owing to the success of FMT, two new non-invasive donor dependent Food and Drug Administration (FDA) approved therapies have been available since late 2022. This review summarizes all these conundrums regarding CDI and provides clinical pearls to use in day-to-day practice.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
    Journal:  Clostridioides difficile infections: Update and therapeutic guidelines (Pubmed Central) -  Oct 8, 2024   
    This review summarizes all these conundrums regarding CDI and provides clinical pearls to use in day-to-day practice. Common treatments include mainly fidaxomicin and oral vancomycin...Bezlotoxumab, an antibody targeting C.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, NN1213 / Novo Nordisk
    Trial completion:  OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) -  Oct 4, 2024   
    P4,  N=308, Completed, 
    Further investigation is needed to determine which patients with CDI may benefit from FDX. Active, not recruiting --> Completed
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal, Real-world evidence, Real-world effectiveness, Real-world:  Real-world effectiveness of fidaxomicin in patients at high risk of Clostridioides difficile recurrence. (Pubmed Central) -  Sep 20, 2024   
    In a real-world high-risk patient population, the use of FDX compared to oral VAN did not result in decreased CDI recurrence within 4 weeks or fewer hospital readmissions within 90 days. Further research is needed to better assess the value of FDX in this patient population.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
    Review, Journal:  Diagnostic and therapeutic management of Clostridioides difficile infection. (Pubmed Central) -  Sep 14, 2024   
    Surgery is indicated in patients with worse prognosis and complications. Prevention is essential, based on vigilance and contact precautions, in addition to the elimination of spores from the environment.
  • ||||||||||  Taigexyn (nemonoxacin) / TaiGen
    Preclinical, Journal:  Potential effectiveness of parenteral nemonoxacin in the treatment of Clostridioides difficile infections: in vitro, ex vivo, and mouse studies. (Pubmed Central) -  Sep 4, 2024   
    However, the standard agent for treating CDIs is limited to oral fidaxomicin or vancomycin...For clinical isolates and laboratory strains, lower MICs of nemonoxacin against C. difficile than levofloxacin and ciprofloxacin were observed, even in those harboring point mutations in the quinolone-resistance determining region...Similarly, no significant differences were found between mice receiving combination therapy of intraperitoneal nemonoxacin plus oral vancomycin and those treated with intraperitoneal nemonoxacin or oral vancomycin alone. The potential role of nemonoxacin, which can be administered parenterally, for treating CDIs was evidenced through the in vitro, ex vivo, and mouse models.
  • ||||||||||  vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
    Journal:  Management of Clostridioides difficile infection: an Italian Delphi consensus. (Pubmed Central) -  Sep 2, 2024   
    Delphi methodology was used to achieve consensus on the management of CDI, on the identification of patients at risk of recurrences or severe infection, and on the most appropriate use of fidaxomicin, with the final aim of fostering clinical practice application of treatment algorithms proposed by previous guidelines, in absolute synergy. It could be an important tool to promote more appropriate and cost-effective CDI treatments in European settings with limited resources, like Italy.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas, NN1213 / Novo Nordisk
    Enrollment closed, Enrollment change:  OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) -  Aug 21, 2024   
    P4,  N=308, Active, not recruiting, 
    It could be an important tool to promote more appropriate and cost-effective CDI treatments in European settings with limited resources, like Italy. Recruiting --> Active, not recruiting | N=549 --> 308
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Recurrent Clostridioides difficile Infection in Crohn's Disease: A Case Series (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_4907;    
    The majority of clinical trials on CDI treatments exclude patients with IBD, which leaves treatment guidance relatively vague. The four cases above demonstrate how treatment is often customized based on the individual patient, and underline the need for clinical trials on recurrent CDI in the IBD population in order to optimize therapy.
  • ||||||||||  Vowst (fecal microbiota spores, live-brpk) / Seres Therap, Nestle
    Efficacy of Microbiome Modulation With SER-109 for Recurrent Clostridium difficile Infection: A Case Report (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_4291;    
    This case supports the growing evidence that microbiome therapeutics like SER-109 can offer durable solutions for rCDI. Future research should focus on long-term outcomes, optimal dosing regimens, and the potential application of similar therapies for other microbiota-related gastrointestinal disorders.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Pneumatosis Intestinalis: An Unusual Complication of Pseudomembranous Clostridioides difficile Colitis (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_4266;    
    Subsequent stool testing confirmed the presence of C. difficile toxins A and B. The patient underwent conservative treatment with Fidaxomicin, showing gradual improvement in diarrhea, leading to discharge to a skilled nursing facility...Image B: Pseudomembranous colitis within the sigmoid colon. Image C: Pseudomembranous colitis within the rectum.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Visceral Kaposi Sarcoma in a Critically Ill Patient With Ulcerative Colitis and History of Liver Transplant (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_3198;    
    The patient was found to have CDI and initially improved with fidaxomicin, but then was subsequently re-admitted for bloody diarrhea...Absence of cutaneous lesions, as in this case, is rare and could lead to delay in diagnosis. In addition, gastrointestinal KS is usually asymptomatic, yet our patient had a rare presentation with diarrhea and hematochezia.[2] Thorough evaluation is imperative to evaluate all potential causes of UC flare-like symptoms.
  • ||||||||||  A Case of Severe ICI-Colitis With Suprainfection (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_2558;    
    Case Description/ An 81-year-old male with metastatic melanoma on nivolumab and relatlimab with biopsy-proven ICI colitis ( Figure 1A ) on prednisone initially presented to the hospital with diarrhea...He was then started on infliximab and ganciclovir with initial symptom improvement...GI pathogen panel confirmed C. diff infection, and the patient was started on fidaxomicin...Severe colitis (i.e., grade 3 or 4) may require steroid therapy in addition to infliximab or vedolizumab, usually dosed at 0, 2, and 6 weeks, and patients typically respond within a week...(A) Colonic mucosal inflammation and ulceration in immune checkpoint inhibitor-colitis. (B) Severe diffuse pseudomembranous colitis in setting of Clostridium difficile infection.
  • ||||||||||  Rituxan (rituximab) / Roche
    Perforation Risk Versus Mortality Benefit: The Quandary of Rituximab in Treating Post-transplant Lymphoproliferative Disorder (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_2527;    
    He had a prior admission for PTLD therapy initiation with rituximab, complicated by C. difficile, treated with fidaxomicin...He underwent laparoscopy with ileocecectomy and end ileostomy and started on meropenem and micafungin...However, 5-10% of patients treated with rituximab for malignancy experience a gastrointestinal perforation due to tumor lysis, presenting significant risks and complications, as highlighted by this case. Clinicians must be aware of these risks to ensure prompt intervention and management, potentially avoiding lethal outcomes.
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    PCR Positive with Toxin Negative Stool and Underlying Severe Clostridioides difficile Infection (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_2521;    
    She was also treated for a UTI with cefepime and meropenem for pneumonia, but her clinical status worsened...After clinical improvement, she was transitioned to fidaxomicin 200 mg q12H and her vasculitis-induced respiratory failure improved with steroids and anticoagulation permitting extubation...If endoscopic appearance is classic and histology confirms active CDI, we recommend treatment regardless of confirmatory CDI testing results. Figure: A.Pseudomembranous Colitis B.Sigmoid Ulcer
  • ||||||||||  Dificid (fidaxomicin) / Merck (MSD), Astellas
    Cyclospora cayetanensis or Clostridium difficile : Who Caused the Diarrhea? (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_784;    
    This posed a dilemma for the clinicians as the patient was suffering from diarrhea even when she had tested negative for Clostridium difficile, but she recovered only when fidaxomicin was prescribed...This case report serves as a unique opportunity to explore the possible mechanisms, if any, regarding how Cyclospora infection or colonization may predispose individuals to C. difficile infection. Figure: Suggested guidelines for the management of C. difficile infection