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Fighting Resistance: How “Antibiotic Stewardship” is Shaping the Utilization of Antibiotics with a focus on antibiotics with new mechanisms of action in development
Ticker(s): SMMTName: Dr Richard Martinello - MD
Institution: Yale University
- Medical Director for Yale's Infection Prevention Department seeing approximately 2 C. Difficile cases per week.
- Oversees Hospital and System efforts to decrease healthcare associated C. Difficile and member of the System's Antibiotic Stewardship Program.
- Research interests include investigation into the epidemiology, impact and transmission of healthcare associated infections including methicillin resistant Staphylococcus aureus, Clostridium difficile and ventilator associated pneumonia.
Summit is developing new mechanism antibiotics for the treatment of serious infections.
Summit's strategy focuses on developing new mechanism antibiotics:
- Designed to be specific to a pathogen or infection.
- Aimed at meeting the unmet needs of patients and healthcare providers.
- Developed to be commercially attractive with compelling value for payors and healthcare systems.
Please describe your background and clinical experience treating infections. What involvement do you have in Antibiotic Stewardship in your health system?
Added By: joe_mccannWe've heard a lot about antibiotic resistance in the media lately and talk about it from companies. Can you give us an overview of the topic with more of a focus on the perspective of data and clinical outcomes you experience and see?
- How rapidly is this issue changing?
- What sort of impact is it having on patients now? Is the biggest issues an inability to cure, resistance, something else?
Can you describe broadly what "Antibiotic Stewardship" looks like at your institution. How has it changed the way you treat infections and how effective is this strategy?
Added By: joe_mccannHow do you currently manage C. Diff infections? What are the largest shortcomings with current treatments and are those shortcomings changing?
In April of 2017, the results of a Phase 2 trial were published in The Lancet. The trial evaluated ridinilazole vs. vancomycin in the treatment of C difficile infection. Can you comment at a high level on those results and the trial design?
On a scale of 1-10 how excited about ridinilazole as a potential front line therapy in treating C. Diff based on current results?
Added By: joe_mccannDespite Phase 2 enrollment being lower than desired, the trial met statistical significance of superiority over Vanco at the 10% level. How do you think about those 2 facts when evaluating the strength of the Phase 2 data?
In the study comparing Ridinilazole and Vancomycin changes in the patients' microbiota were assessed using qPCR. The results found: "Analyses showed profound losses of Bacteroides, C. coccoides, C. leptum, and Prevotella groups at EOT with vancomycin treatment, while ridinilazole-treated participants had a modest decrease in C. leptum group levels at EOT, with levels recovering by Day 25. Vancomycin-treated participants had a significant increase in the Enterobacteriaceae group, with this increase persisting beyond EOT. At EOT, alpha diversity decreased with both anti-biotics, though to a significantly lesser extent with ridinilazole (p <0.0001)." How do you interpret these results with respect to clinical relevance and evidence of narrow spectrum activity?
Added By: joe_mccannHow has the landscape for patient enrollment changed recently in C. Diff? The company has pointed to a competitive trial enrollment landscape during their Phase 2 trial. Has that improved at all?
Added By: joe_mccannAre You Interested In These Questions?
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