 |
11 Diseases |  |
2 Trials |
|
2 Trials |  |
1263 News |  |
| «12...345678910111213...1617» |
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
One of these days Fidaxomicin will be there (Twitter) - Jan 31, 2022
- Remicade (infliximab) / Merck (MSD), Mitsubishi Tanabe, J&J, Zinplava (bezlotoxumab) / Merck (MSD), Entyvio (vedolizumab) / Takeda
BEZLOTOXUMAB THERAPY FOR RECURRENT CLOSTRIDIUM DIFFICILE INFECTION IN AN ULCERATIVE COLITIS PATIENT () - Jan 28, 2022 - Abstract #CCCongress2022CCCongress_366;
She was treated with 125mg oral vancomycin, four times daily, and tapered down by one dose over a four-month period...She was treated with 14-day course fidaxomicin 200mg BID and a single infusion of bezlotoxumab 10mg/kg...This case corroborates the prospect that bezlotoxumab positively affects the clinical outcomes of UC patients with rCDI compared to those on repetitive antimicrobial therapy and/or FMT without mAB therapy. Further investigation into the long-term efficacy of this therapy is merited for the IBD patient population in the real-world setting.
- | SER-109 / Seres Therap
Journal: SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection. (Pubmed Central) - Jan 27, 2022
P3
The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128.).
- || Dificid (fidaxomicin) / Merck (MSD), Astellas, ridinilazole (SMT 19969) / Summit Therap, Eurofarma, cadazolid (ACT-179811) / J&J
Review, Journal: Inhibition of spores to prevent the recurrence of Clostridioides difficile infection - A possibility or an improbability? (Pubmed Central) - Jan 26, 2022
Clostridioides difficile is one of the most common nosocomial gastrointestinal pathogens, and recurrence is a problematic issue because approximately 20-30% of patients experience at least one episode of recurrence, even after treatment with a therapeutic drug of choice for C. difficile infection (CDI), such as vancomycin...However, an antimicrobial agent, such as fidaxomicin, which has a good inhibitory effect on both C. difficile vegetative cells and spores is assumed to not only treat CDI but also prevent its recurrence...Some new antimicrobial agents in phase II clinical trials, including cadazolid and ridinilazole, have shown exceptional anti-C. difficile and spore-inhibiting effects that can be expected to not only treat CDI but also prevent its recurrence in the future.
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical guideline, Journal: Evaluation of fidaxomicin use in community hospitals after a clinical guideline change at a large health system and opportunities for stewardship. (Pubmed Central) - Jan 26, 2022
Half (50%) of regimens were adherent to our guidelines, with infectious diseases (ID) providers were frequently nonadherent. Antimicrobial stewardship programs are important for facilitating best practices, even among ID specialists.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Association between prevalence of laboratory-identified Clostridioides difficile infection (CDI) and antibiotic treatment for CDI in US acute-care hospitals, 2019. (Pubmed Central) - Jan 26, 2022
The prevalence rate of LabID CDI had a significant dose-response association with first-line antibiotics for treating CDI. We identified hospitals with extreme discordance between CDI prevalence and CDI AU, highlighting potential opportunities for data validation and improvements in diagnostic and treatment practices for CDI.
- |||||||| Dificid (fidaxomicin) / Merck (MSD), Astellas
New P3 trial: Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin (clinicaltrials.gov) - Jan 20, 2022
P3, N=98, Recruiting, Sponsor: Mikrobiomik Healthcare Company S.L.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Microbiota diversity and bacterial load after successful treatment of Clostridioides difficile infection with honey lavage in 4 patients. (Pubmed Central) - Jan 18, 2022
First, the patients received a three-day fidaxomicin treatment...The four patients experienced complete cessation of watery stools and remain symptom free. These results indicate the need for more clinical research into this matter.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Journal, HEOR: Cost-effectiveness of bezlotoxumab and fidaxomicin for initial Clostridioides difficile infection. (Pubmed Central) - Jan 11, 2022
Based on a WTP threshold of $150 000, standard fidaxomicin was estimated to be the most cost-effective treatment. Standard-of-care vancomycin was dominated by extended-pulsed fidaxomicin for treating an episode of CDI and preventing further recurrence, and the addition of bezlotoxumab to vancomycin was dominated by standard fidaxomicin.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
Clinical, Journal: European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. (Pubmed Central) - Jan 8, 2022
Important changes compared with previous guideline include but are not limited to: metronidazole is no longer recommended for treatment of CDI when fidaxomicin or vancomycin are available, fidaxomicin is the preferred agent for treatment of initial CDI and the first recurrence of CDI when available and feasible, FMT or bezlotoxumab in addition to standard of care antibiotics (SoC) are preferred for treatment of a second or further recurrence of CDI, bezlotoxumab in addition to SoC is recommended for the first recurrence of CDI when fidaxomicin was used to manage the initial CDI episode, and bezlotoxumab is considered as an ancillary treatment to vancomycin for a CDI episode with high risk of recurrence when fidaxomicin is not available. Contrary to the previous guideline, in the current guideline emphasis is placed on risk for recurrence as a factor that determines treatment strategy for the individual patient, rather than the disease severity.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Is There a Future for a Tapered-Pulsed Fidaxomicin Regimen for Pediatric Patients With Recurrent Clostridiodes difficile Infections? (Pubmed Central) - Jan 8, 2022
Contrary to the previous guideline, in the current guideline emphasis is placed on risk for recurrence as a factor that determines treatment strategy for the individual patient, rather than the disease severity. No abstract available
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Myxopyronin B inhibits growth of a Fidaxomicin-resistant Clostridioides difficile isolate and interferes with toxin synthesis. (Pubmed Central) - Jan 8, 2022
Moreover, mass spectrometry analysis indicated that Myxopyronin B is able to suppress early phase toxin synthesis in C. difficile to the same degree as Fidaxomicin. Conclusively, Myxopyronin B is proposed as a new lead structure for the design of novel antibiotics for the therapy of C. difficile infections.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Review, Journal: Fecal microbiota transplantation for recurrent Clostridioides difficile, safety, and pitfalls. (Pubmed Central) - Jan 8, 2022
Microbiome-based therapies are being developed to eliminate the logistical challenges related to FMT. Large prospective and placebo-controlled studies are needed to evaluate the efficacy and long-term safety of FMT, so its use can be justified in clinical practice.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal, HEOR: Comparative Effectiveness of Early-Targeted Use of Fidaxomicin versus Oral Vancomycin among Hospitalized Veterans' Affairs Patients with Infections due to Clostridioides difficile. (Pubmed Central) - Jan 7, 2022
Large prospective and placebo-controlled studies are needed to evaluate the efficacy and long-term safety of FMT, so its use can be justified in clinical practice. This real-world effectiveness study suggests that use of fidaxomicin potentially results in better outcomes relative to oral vancomycin for initial treatment of hospitalized VAMC patients with CDIs.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, NN1213 / Novo Nordisk
Trial completion date, Trial primary completion date: OpTION: Optimal Treatment for Recurrent Clostridium Difficile (clinicaltrials.gov) - Dec 29, 2021
P4, N=549, Recruiting, Sponsor: VA Office of Research and Development
This real-world effectiveness study suggests that use of fidaxomicin potentially results in better outcomes relative to oral vancomycin for initial treatment of hospitalized VAMC patients with CDIs. Trial completion date: May 2022 --> Dec 2023 | Trial primary completion date: May 2022 --> Dec 2023
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Systems biology evaluation of refractory Clostridioides difficile infection including multiple failures of fecal microbiota transplantation. (Pubmed Central) - Dec 25, 2021
This study highlights the importance of antimicrobial stewardship in patients receiving FMT. Continued antibiotics play a destructive role on a transplanted microbiome and applies selection pressure for resistance to the few antibiotics available to treat CDI.
- | ceftriaxone / Generic mfg., rifampicin / Generic mfg., amoxicillin / Generic mfg.
Journal: Antimicrobial Resistance Progression in the United Kingdom: A Temporal Comparison of Clostridioides difficile Antimicrobial Susceptibilities. (Pubmed Central) - Dec 25, 2021
Antibiotic resistance in CD has increased since the early 1980s, across the majority of classes. Moxifloxacin resistance determinants may pre-date its introduction.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Antibiotic Resistances and Molecular Characteristics of Clostridioides difficile in ICUs in a Teaching Hospital From Central South China. (Pubmed Central) - Dec 24, 2021
The most prevalent was ST3, and all ST26 isolates were NTCD. Although multidrug resistance was present in ≥50% of the C. difficile isolates, metronidazole, tigecycline, fidaxomicin, and vancomycin were still effective treatments for CDI in our hospital.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Frontiers in antibiotic alternatives for Clostridioides difficile infection. (Pubmed Central) - Dec 18, 2021
The next epidemic of CDI is not a matter of if but a matter of when. Therefore, being well-equipped with a collection of alternative therapeutics is necessary and should be prioritized.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Effectiveness of fidaxomicin versus oral vancomycin in the treatment of recurrent clostridioides difficile. (Pubmed Central) - Dec 16, 2021
However, the current study is limited by the small sample size available for inclusion. Prospective randomized studies with larger sample sizes are needed to confirm this study's conclusions.
- ||| vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas, Cubicin (daptomycin) / Merck (MSD)
Clinical, HEOR: The value of generic linezolid, daptomycin, branded fidaxomicin outweigh indirect costs of vancomycin (labor, TDM, ADE/nephrotoxicity). Lessons in hospital economics vs pharmacoeconomics. (Twitter) - Dec 15, 2021
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Retrospective Analysis of the Prevalence of Fidaxomicin Hypersensitivity in Patients with Reported Macrolide Allergy ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_3791;
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Evaluation of Recurrent Clostridioides difficile Infections in Lung and Heart Transplant Recipients Who Received Secondary Prophylaxis with Vancomycin or Fidaxomicin ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_3127;
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Comparing Fidaxomicin to Oral Vancomycin in the Risk of Recurrent C. difficile Infections ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_2420;
- Dificid (fidaxomicin) / Merck (MSD), Astellas
Fiscal Impact of Fidaxomicin Implementation for the Treatment of Clostridioides Difficile Infection in Adults Based on Recent Infectious Diseases Society of America Guideline Updates ([VIRTUAL]) - Dec 2, 2021 - Abstract #ASHP2021ASHP_827;
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Real-life experience with fidaxomicin in Clostridioides difficile infection: a multicentre cohort study on 244 episodes. (Pubmed Central) - Nov 29, 2021
We conclude that the outcomes with fidaxomicin in real life are at least as good as those observed in clinical trials despite a more demanding evaluation. Be it 85 years of age or older, and the use after a first episode appears to be independent factors of CDI recurrence after treatment with fidaxomicin.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Visualization of fidaxomicin association with the exosporium layer of Clostridioides difficile spores. (Pubmed Central) - Nov 29, 2021
This study visualized a direct attachment of fidaxomicin to C. difficile spores that was diminished with mutants of specific exosporium and spore coat proteins. These data provide advanced insight regarding the anti-spore properties of fidaxomicin.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Antibiotic Therapies for Clostridioides difficile Infection in Children. (Pubmed Central) - Nov 21, 2021
Additionally, observational data published since the IDSA/SHEA guidelines were released suggest metronidazole has lower rates of clinical improvement when compared to vancomycin in hospitalized children with non-severe CDI. Given these recent publications, fidaxomicin and vancomycin, instead of metronidazole, appear to be more appropriate, evidence-based options for the treatment of CDI in children.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas, Cdactin-O (CBM-588) / Osel, Miyarisan
Journal: Clostridium butyricum enhances colonization resistance against Clostridioides difficile by metabolic and immune modulation. (Pubmed Central) - Nov 7, 2021
Additionally, CBM 588 upregulated T cell-dependent pathogen specific immunoglobulin A (IgA) via interleukin (IL)-17A producing CD4 cells and plasma B cells in the cLP, and Th17 cells in the cLP enhanced the gut epithelial barrier function. IL-17A and succinic acid modulations with CBM 588 enhance gut colonization resistance to C. difficile and protect the colon tissue from CDI.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Preclinical, Journal: High-throughput screening identifies a novel natural product-inspired scaffold capable of inhibiting Clostridioides difficile in vitro. (Pubmed Central) - Nov 5, 2021
Further in vitro investigation revealed that the compounds were nontoxic to Caco-2 cell line. Given their potent anticlostridial activity, natural product-inspired scaffolds may suggest potential avenues that can address the unmet needs in preventing C. difficile mediated disease.
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: Trying out the preprint thing. Let's see how that goes Fidaxomicin as first line: what will it cost in the USA/Canada Fingers crossed for first author medical student Dr. Devangi Patel,.pharmD @DrEmilyMcD @BradSpellberg @ASPphysician @AntibioticDoc https://t.co/aK3geXAVUB (Twitter) - Nov 4, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Pricing: Great discussion by @DrToddLee about the upfront cost of fidaxomicin vs cost saved with CDAD recurrence. The problem of different $ buckets in healthcare. @mlbrownrx @TMcCarty2010 @SEdwardsPharmD @DrJeanneM (Twitter) - Oct 23, 2021
- ||| vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: Non-severe initial episode: vancomycin or fidaxomicin IDSA: never use metronidazole @AmCollegeGastro: can use metronidazole in low-risk patients (Twitter) - Oct 23, 2021
- ||| Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: In lieu of preprint in case target journal does not allow. A discussion of fidaxomicin as first line for CDAD Devangi Patel, Julien Senécal, Brent Footer @ABsteward @ASPphysician @DrEmilyMcD @AntibioticDoc @BradSpellberg (Twitter) - Oct 23, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
100% for fidaxomicin. I can't understand the logic with regard to the price (Twitter) - Oct 22, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas, Baxdela (delafloxacin) / Menarini, Melinta Therap
Yes they would still develop new drugs I am 100% convinced the return on investment for fidaxomicin would have been net higher if the price was more realistic. As to delafloxacin? That isn't selling because what's the market? (Twitter) - Oct 22, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Diagnosis and management of Clostridioides difficile infection in patients with inflammatory bowel disease. (Pubmed Central) - Oct 20, 2021
Therefore, all patients with worsening gastrointestinal symptoms should be evaluated for both CDI and IBD exacerbation. Providers should consider FMT for all patients with recurrent CDI as well as escalation of immunosuppression for patients who fail to improve with appropriate antimicrobial therapy.
- | Dificid (fidaxomicin) / Merck (MSD), Astellas
Journal: Cutting edges in Clostridioides difficile infections. (Pubmed Central) - Oct 19, 2021
Newer therapy options such as fidaxomicin, the administration of monoclonal antibodies or faecal microbiota transplantation demonstrate significant advantages over traditional therapies, particularly regarding the reduction of the recurrence rate. This article highlights the main differences between the recommendations of the Swiss Society for Infectious Diseases on the management of "Clostridioides difficile infection" and the IDSA/SHEA reference guideline "Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA)" and discusses some important challenges in -treatment of C. difficile.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal, Polymerase Chain Reaction: Kinetics of polymerase chain reaction positivity in patients with Clostridioides difficile infection. (Pubmed Central) - Oct 15, 2021
The median time to negative PCR in CDI was 9 days from treatment initiation. The PCR positivity during or after treatment may be useful for recurrence prediction; larger studies are needed to validate these results.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: Fidaxomicin for the treatment of Clostridioides difficile in children. (Pubmed Central) - Oct 15, 2021
An investigator-blinded, randomized, multicenter, multinational clinical trial comparing the efficacy and safety of fidaxomicin with vancomycin in children was recently published confirming similar findings as previously reported in adults. Fidaxomicin is the first FDA-approved treatment for CDI in children and offers a promising option for reducing recurrent CDI in this population.
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
*fidaxomicin (Twitter) - Oct 11, 2021
- ||| vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical: Is given in conjunction with standard of care treatment. In this case that would be fidaxomicin or Vancomycin. (Twitter) - Oct 10, 2021
- |||| vancomycin / Generic mfg., Dificid (fidaxomicin) / Merck (MSD), Astellas
Reimbursement, Medicare: Online in #ClinInfDis from @deannabuehrle & me: Access to oral vancomycin & fidaxomicin, @IDSAInfo @SHEA_Epi endorsed frontline treatments for C difficile infections, is limited by tier 4 or 5 formulary positioning in Medicare plans for almost everyone. https://t.co/HQ0dBtvDl0 (Twitter) - Oct 9, 2021
- || Dificid (fidaxomicin) / Merck (MSD), Astellas
Clinical, Journal: A Tapered-Pulsed Fidaxomicin Regimen following Treatment in Patients with Multiple Clostridioides difficile Infection Recurrences. (Pubmed Central) - Oct 9, 2021
Sustained clinical response rates at 30 and 90 days were 74% (34/46) and 61% (28/46). T-P fidaxomicin shows promise for management of mrCDI.
- | Xifaxan (rifaximin) / Alfa Wassermann, Bausch Health, Norgine, ASKA Pharma
Journal: Treatment of Clostridioides difficile infection. (Pubmed Central) - Oct 7, 2021
T-P fidaxomicin shows promise for management of mrCDI. No abstract available
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] Complications and Hospital Resource Utilization among Patients with Bacterial Nosocomial Pneumonia in the US, 2012-2019 () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_2217;
VABP was associated with the longest post-infection ICU LOS and highest hospital costs. 1 Zilberberg et al.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] The Burden of Illness Associated with Recurrent Clostridioides difficile Infection: A Claims-based Analysis () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1657;
Results from this observational analysis suggest that the presence of CDI seems to lead to a considerable increase in HCRU after the initial episode. Despite variation in treatment patterns by episode, some HCRU seems to increase with additional episodes.
- vancomycin / Generic mfg.
[VIRTUAL] Impact of Two-Step Testing Algorithm on Hospital-onset Clostridioides difficile Infections and Oral Vancomycin Prescription Practices at an Academic Medical Center () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1655;
There was no impact on the rate of oral vancomycin use. We observed at 54% rate of treatment for patients categorized as likely colonization.
- Dificid (fidaxomicin) / Merck (MSD), Astellas
[VIRTUAL] Real-World Utilization of C. difficile Drug Treatments and Associated Clinical Outcomes in a US Hospital System () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1654;
Implementation of the CDI order set increased fidaxomicin use and was associated with a decrease in CDI recurrences and CDI-related readmissions and increase in clinical cure and sustained response. Findings suggest increased first-line use of fidaxomicin results in better clinical outcomes.
- Dificid (fidaxomicin) / Merck (MSD), Astellas, Zinplava (bezlotoxumab) / Merck (MSD)
[VIRTUAL] Evaluating Use of the New ICD-10 Codes for Clostridioides difficile Infection in the Premier U.S. Hospital Discharge Database () - Oct 6, 2021 - Abstract #IDWeek2021IDWeek_1649;
There was no delay in transition to the new CDI-related ICD codes across hospitals in the PHD. Important for disease management, drug treatment trends for encounters coded as rCDI vs. nrCDI were consistent with guideline-recommendations for CDI.