to discuss the 3 major overlapping issues of infection control practices, 

Petrosillo gave a presentation entitled “The Burden of 

 Infection In the COVID-19 Era,” virtually on November 4 during 

Petrosillo is an infectious disease specialist who was on the frontlines of COVID-19 in Italy; he saw and treated the first 2 confirmed cases of COVID-19 in Rome.

Petrosillo earned a Doctorate in Medicine and Surgery from the University “La Sapienza” in Rome, Italy in 1977. A few years later, at the same University, he became a specialist in Infectious Diseases (1981) and in Internal Medicine (1985). He is a member of the Professional Affairs Subcommittee on Infectious Diseases and the Advisory Board of the Trainee Association of ESCMID. Petrosillo is currently the Head Infection Control and Infectious Disease Service at the University Hospital Campus Bio-Medico in Rome, Italy.

In his multi-center study in Italy, Petrosillo found CDI incidence among hospitalized COVID-19 patients was similar to that of the general population the year before (~4 cases per 10000 patient days).

The study identified CDI risk factors, such as hospitalization or the use of antimicrobials. During the peak of the pandemic, doctors were much more concerned with saving the lives of individual patients than controlling antibiotic dispersal, leading to poor antimicrobial stewardship.

Overall, CDI cases decreased during the pandemic, likely due to increased attention to hygiene practices like handwashing. However, Petrosillo noted that some CDI cases may have been overlooked during the pandemic due to some symptoms, such as diarrhea, being dismissed as symptoms of COVID-19.

Videos

Dr. Nicola Petrosillo discusses treating C difficile infection and maintaining antimicrobial stewardship during the height of the COVID-19 pandemic in Italy.

Fighting C Difficile Infection during the COVID-19 Pandemic

World Anti-Microbial Resistance (AMR) Congress

. The congress was in-person in Washington, DC, but 

 is covering some of the most critical presentations from the 2-day conference.

AMR Awareness Campaigns: Communicating with Stakeholders AND the Unaware

This presentation was given by Sepsis Alliance President and CEO, Thomas Heymann, and Director of Communications, Alex Sadorf. Sepsis is the body’s extreme reaction to an infection, and though 1.7 million people are affected by sepsis each year, the condition is not widely known.

Any untreated infection can lead to sepsis, and AMR inhibits the treatment of some infections, thus increasing the risk of sepsis. As fewer drugs work effectively against infectious pathogens, sepsis cases will become increasingly difficult to treat, and there will be more mortalities among sepsis patients.

Sepsis Alliance conducted a global survey to understand the public’s knowledge of AMR, in Brazil, China, India, Spain, and the US. The results showed that only 52% of adults had heard of the term “antimicrobial resistance”; awareness was much higher for the term “antibiotic resistance.” Globally, many adults could not identify potential complications of an infection.

Sepsis Alliance found a troubling lack of awareness, knowledge, and understanding of AMR. The challenge of communicating this complex topic is complicated by Sepsis Alliance’s goal to reach medical providers and the general public, all of whom have differing levels of knowledge about AMR and its effects.

The goal of Sepsis Alliance is to make the public aware that they can actively prevent AMR. To do this, they employed the pneumonic 

 in their informational advertising campaigns: 

ractice good hygiene and get vaccinated, 

emain vigilant to avoid the risk of infection.

UK – A global AMR powerhouse: Opportunities and benefits through joint innovation and international collaboration

Because AMR can spread internationally, it must be fought internationally. Phil Packer, Innovation Lead of AMR and Vaccines at Innovate UK, and Maarten van Dongen, Director of AMR INSIGHTS Netherlands, gave a presentation on the collaborative efforts of several countries to create real solutions to stop AMR.

Dongen introduced AMR INSIGHTS and its work to inform, educate, and connect people on topics related to AMR. One such project is the development of a gamified program to improve antibiotic prescription. It is a 3-part series, consisting of a survey tool (“Are you resistant?”), a serious game (“Prescription Challenge”), and finally an online diagnostic tool.

Packer introduced AIMRAR, “An Integrated Microfluidic single cell Raman technology for rapid diagnosis of pathogens and their Antibiotic Resistance.” AIMRAR was developed and sponsored by researchers and companies in the UK and China.

Another recent development from the UK and China is Destiny Pharma: XF-73, a drug with antibacterial properties that combats biofilms. Packer said success of this enabled them to leverage it for more funding for bigger projects in the future.

Ideally, Packer wants the UK and US to collaborate on these innovations, holding an event to bring together scientists from both countries to pool their expertise on various areas of AMR.

Packer and Dongen stressed their mission of joint innovation and international collaboration, with a plan that includes early and translational research, research and development, microbial diagnostics, antimicrobial products, and vaccines.

Articles

Antimicrobial resistance is a growing problem that requires international collaboration to educate the general public and stakeholders, while simultaneously developing solutions.

Anti-Microbial Resistance Education and Innovation Efforts

Today marked the start of the 2-day World Anti-Microbial Resistance Congress 2021, which is being held in Washington, DC. The conference offered on-demand content to view important presentations.

Michael Craig, director, Antibiotic Resistance Coordination and Strategic Unit, National Centers for Emerging and Zoonotic Infectious Diseases, presented his session, Prioritizing Prevention: How We Get Ahead of the Global Threat for of AMR. Craig discussed the prevention lessons learned during the COVID-19 pandemic.

We get what we pay for now. Specifically if we don’t invest in public health capacity and prevention we will not have these when we need them: early detection and containment; response capacity to stop transmission; infection control; and evidence based prevention interventions including vaccines and preventatives; and

Preparedness is not exercises, tabletops and planning documents alone. No amount of hypothetical planning will prepare us for an unknown threat if we cannot address our localized outbreaks and known endemic threats.

Craig then posed the question, if we do not seriously invest in preventing known threats like antibiotic-resistant infections, should we be confident that we can adequately address new emerging threats?

He said the ability to prevent AMR infections is about preparedness. New and emerging threats happen regularly in AMR, and investing in AMR prevention tools provides resiliency. Staff and laboratory well trained to stop current outbreaks. These investments would keep us from dividing our attention when new threats emerge.

Najy Alsayed, MD, head of Disease Area, Infectious Diseases Menarini Group presented his session, The contribution of Real-World-Data in AMR: Which studies and why? Alsayed discussed examining real world data (RWD) and real world evidence (RWE).

For the former, RWD is an umbrella terms to describe :

Effects of disease: patient characteristics, clinical and economic outcomes, health related quality of life

Healthcare interventions (e.g. safety, effectiveness, resource use)

Primary research data: intervention use in routine clinical practice

Secondary research data: from routine practice collected data.

Alsayed pointed out the FDA and EMA use RWD and RWE to monitor post market safety and adverse events to make informed regulatory decisions.

The paradox of AMR, explained Alsayed, was the rise of AMR and the increasingly thin new antibiotic availability. He pointed at that from 1983 to 1987 there were 16 new antibiotic agents and that from 2008 to 2012 there were only 2 new antbiotics.

He went on to say there were a number of reasons for this including suboptimal new antibiotic approval and poor patient access to antimicrobials.

Alsayed pointed to three areas where RWD contributions may improve access to new antimicrobials, including:

Allowing rational use vs current rationed use

Allowing targeted patient treatment approach

Demonstrating new antimicrobials benefit to both patients and the healthcare system.

World Anti-Microbial Resistance Congress

Highlights from the sessions of the World Anti-Microbial Resistance Congress 2021 included addressing the global threat for AMR and looking at real world data and real world evidence to deter resistance.

How Real World Data and Preparedness are Needed in Fight Against for AMR

Today marked the beginning of the 2-day World Anti-Microbial Resistance Congress (AMR). Held in-person in Washington, DC, it is the largest AMR conference in the world. AMR is a high priority for the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), and representatives from both organizations gave presentations on the strategies they have enacted to fight AMR.

 is covering both days of the event; read on for 

Actions needed to increase the role of vaccines in preventing AMR: WHO strategy and activities

This presentation was given by Mateusz Hasso-Agopsowicz, Technical Officer for the World Health Organization (WHO). Hasso-Agopsowicz began by emphasizing the direness of AMR, as 2.4 million deaths are predicted across Europe, North America, and Australia from 2015-2050 due to AMR. Worldwide, 28 million people are anticipated to become impoverished due to AMR, and healthcare costs may increase by up to $1 trillion by 2050.

Hasso-Agopsowicz and WHO are working to spread the message that vaccines are crucial in the fight against AMR. WHO’s plan has 3 strategic goals: (1) expand the use of licensed vaccines to maximize impact on AMR, (2) develop new vaccines that contribute to prevention and control of AMR, and (3) expand and share knowledge of vaccine impact on AMR.

To meet these goals, WHO is supporting countries that are creating their own National Action Plans against AMR, as well as educating countries about which vaccine investments should be made to prevent AMR. Hasso-Agopsowicz encouraged understanding the landscape of licensed and developing vaccines that fight WHO priority pathogens, tuberculosis and 

The pandemic’s silver lining: Opportunities to improve IPC and AMR containment in low- and middle-income countries

Benjamin Park, Chief of the International Infection Control Program for the Centers for Disease Control and Prevention (CDC), discussed a potential benefit of the devastating COVID-19 pandemic: increased infection prevention and control (IPC) and AMR containment

Park focused on infections that the CDC designates as “critical,” the carbapenem-resistant species 

. Carbapenem-resistant organisms (CROs) are concerning because for many countries, carbapenems are the most powerful antibiotic available. Infection with a CRO has a mortality rate of over 50%, and these infections are nearly untreatable. CROs can spread between bacteria, between people (with and without symptoms), between facilities, and between countries.

IPC programs are clinical and public health specialties that enable healthcare systems to safely deliver care. Once identified, IPC teams contain the spread of dangerous, contagious pathogens. The outbreak of COVID-19 has motivated the CDC to improve IPC globally, but especially in low- and middle-income countries (LMIC).

A major post-COVID-19 development Park detailed was that the Global Fund is now available for IPC. The Global Fund is an international organization active in more than 100 countries, focused on AIDS, TB, and malaria. The Global Fund pools global resources to support local organizations, and recognizing that COVID-19 has devastated essential health services, the Global Fund has committed to make IPC funding available through Country Coordinating Mechanism (CCM).

CROs continue to be a public health threat, especially in LMIC, and this disparity is increasing. Spreading across borders means all countries must work together to detect and contain dangerous pathogens at the source.

Anti-microbial resistance is one of the most critical issues in healthcare, and the CDC and WHO addressed these concerns with plans to fight back against AMR at the annual world congress.

WHO and CDC Present Strategies to Combat Anti-Microbial Resistance

9th Annual International C. Diff Conference & Health EXPO

 continued today, more news emerged from the conference.

Investigational antibiotic ibezapolstat is reported to be the first antibiotic candidate intended to work by blocking the Pol IIIC enzyme in 

This therapy is a first-in-class of a new class of Pol IIIC inhibitors in phase 2 trials with this unique mechanism of action.

During his presentation at the conference today, Kevin Garey, PharmD, chair of the Department of Clinical Sciences and Administration and Professor of Pharmacy Practice at the University of Houston College of Pharmacy, shared that in a small phase 2A study, 10 patients with the first occurrence or first reoccurrence 

had 100% cure rate when they were given ibezapolstat and none of the patients had a recurrence.

, Garey acknowledged the size of the first study and that they needed to prove results, which they were able to reproduce.

He pointed out that some of the newer research is shifting towards preserving the microbiome because the current class of approved antibiotics has patients experience recurrent 

“A lot of the drug development now within 

 antibiotics is, ‘will my new compound—ibezapolstat in this case—prevent disruption to the microbiome more favorable to the comparator’ usually vancomycin,” Garey stated.

Garey also provided further insights into the clinical trials, the therapy’s mechanism of action, and why this therapy could be significant in the fight against 

Results on this investigational antibiotic in its phase 2A study were presented at the C Diff. Conference today.  

Ibezapolstat Demonstrates 100% C Difficile Cure, No Recurrence in Small Study 

Today was the second and final day of the 

. A wide variety of topics related to research in and prevention of 

were presented virtually throughout Thursday and Friday, interspersed with panelist discussions.

The following are highlighted presentations from Friday morning and afternoon, but you can find all of 

"Metronidazole For the Treatment of C. difficile Infections: On the Way Out?"

Wiep Klaas Smits, PhD, of the Department of Medical Microbiology Leiden University Medical Center, was the first speaker of the afternoon. Metronidazole has been the staple 

infection (CDI) treatment for a long time, but Smits called metronidazole resistance “complicated,” citing reports of unstable, inducible, and heterogeneous resistance.

Its efficacy is lower than vancomycin and fidaxomicin, and it has a trend of decreasing in efficacy over time. Metronidazole is no longer recommended as a first-line treatment, as it has no clear evidence of resistance or increase in resistance, despite its widespread use.

Tailored susceptibility testing is essential for 

, and Smits also advocated for integrating data on antimicrobial susceptibility, phylogeny, genome characteristics, treatment outcome, and ideally patient genetics.

Smits concluded that metronidazole is an inferior treatment modality, due to its severe resistant pathways and potential transmission of resistance.

“A Four-pronged Threat: Clostridioides difficile Infection (CDI), Antibiotics, the Flu Season, and COVID-19.”

David M. Lyerly, PhD explored the intersections of CDI, antibiotics, influenza, and COVID-19. Beginning with 

he recounted that there were 450000 cases of CDI in the US last year that killed 30000 people, without accounting for comorbidities.

Lyerly echoed talks from yesterday that referenced recurrent CDI as the most challenging part of fighting the virus. Up to 1 in 4 patients with CDI will relapse, with some relapsing multiple times. Because its spores are so difficult to kill, CDI has become the most common 

. CDI is a global disease, and its new variants demand antimicrobial stewardship.

Mitigation effects to reduce COVID-19 also caused a decrease in flu illnesses by more than 98%, and lowered hospital-acquired infections like CDI. However, COVID-19 patients can become co-infected with 

, and vice versa. Dysbiosis has been demonstrated with viral respiratory infections, and dysbiosis involving the intestinal microbiome is a risk factor for CDI. There have been indications that COVID-19 can be treated by restoring a healthy intestinal microbiome, but fecal transplants may transfer COVID-19 infection.

Antibiotic use has been repeatedly traced to negative effects on the gut microbiota, due to reduced species diversity, decreased bacterial metabolic activity, and selection of antibiotic-resistant organisms. Treatment with antibiotics cause a 20% increase in CDI, or approximately tens of thousands of cases.

Ridinilazole:​ A Novel, Investigational, Precision Antibiotic​ for a C. difficile Infection​.

Esther Duperchy, Director of Anti-Infectives Research at Summit Therapeutics, presented on a new antibiotic to fight CDI. Ridinilazole is a highly specific and bactericidal treatment that kills 

 in vitro while preserving the microbiome.

Duperchy noted Ridinilazole’s microbiome-sparing profile, as there were many discussions throughout both days of the conference concerning the negative effects of antibiotics on the microbiome. Ridinilazole also preserves the protective secondary bile acids, while vancomycin reduces these levels. This is significant, as secondary bile acids are significantly lower in patients with recurring CDI.

In the multi-center, double-blind, phase 2 study, Ridinilazole reduced recurrence and exhibited a sustained clinical response. Sustained clinical response was defined as clinical response at the end of therapy with no recurrence for at least 30 days.

Overall, Ridinilazole offered a 60% reduction in CDI recurrence. While Duperchy could not reveal any more about the impending phase 3 trial, she hopes to provide updated results soon.

Sabine Hazan, MD, has over 22 years of experience in clinical research, and calls herself “the queen of 

Hazan voiced her strong opposition of overmedication, saying it negatively affects the microbiome. No microbe is an island, and killing one with an antibiotic has a ripple effect that kills many. This loss of microbiome diversity causes disease.

Various factors affect the microbiome, and antibiotics are one of the major causes. Hazan said, “

 is a basic model of dysbiosis in human disease.” Hazan looked for applications of FMT beyond 

, suggesting that low diversity is correlated with autism. Hazan’s search for applications of FMT beyond CDI was backed by her belief that all sickness and disease can be attributed to imbalances of the gut.

Presentation highlights from the second and final day of the 9th Annual International C. diff Conference & Health Expo.

Conference Coverage: New Challenges and Treatments for C Difficile Infection

Tamás Haidegger, MSc, PhD, Associate Professor at Óbuda University, interviewed with 

 to discuss his research, “Evidence-Based Hand Hygiene in the Post-COVID World.”

Haidegger was one of the presenters on Thursday, November 4 at the 

For the past few years, Haidegger has been working with his team to develop the Semmelweiss Scanner, a technology that improves hand hygiene by identifying areas neglected during handwashing.

The scanner uses AI technology established on digital imaging to identify and quantify missed areas on the hands. It can eventually learn one’s handwashing habits and track the learning curve of hand hygiene. In a hospital setting, this data can be used to monitor certain physicians or wards in need of additional handwashing training.

Haidegger emphasized that hand sanitizer, omnipresent in the age of COVID-19, is not enough to combat 

. Getting rid of this stubborn bacteria requires washing and rubbing all areas of the hands, which Haidegger’s system can teach and encourage.

In addition to cofounding HandInScan, Haidegger is the director of the University Research and Innovation Center (EKIK), and the technical lead of medical robotics research at the Antal Bejczy Center for Intelligent Robotics.

Haidegger invited any hospital or institution that feels it could benefit from digitalized hand hygiene to reach out at 

Dr. Tamás Haidegger talks about his work to develop an AI-based scanner that tracks hand hygiene to prevent C difficile and other infections.

Technology That Tracks Hand Washing Habits to Prevent C difficile Infection

 Conference Co-Chair and Keynote Speaker Paul Feuerstadt, MD, FACG, AGAF

attending gastroenterologist, PACT Gastroenterology Center, makes the point that there are reasons to be optimistic about 

 (CDI) treatment and preventing recurrent CDI. “We are at the precipice of greatness with 

 right now; it is such an exciting time.”

Feuerstadt points to the product pipeline and the promising study data being discussed at the conference.

 stakeholders attending the conference brings together researchers, clinicians, epidemiologists, other health-related providers, and patients to discuss the latest findings and their perspectives with the hope of shedding light on this debilitating infection. “The diversity of the conference is a true strength.” 

Feuerstadt will be leading a group discussion at 1:00pm EDT today titled, 2021 Guidelines: A Path Forward”? They will be discussing the updated 

In a wide-ranging interview, Feuerstadt offers further insights into the various antibiotics and microbiota modalities being presented at the conference, and provides a large picture perspective of the state of 

At the C Diff Foundation Conference, promising investigational modalities and therapies, as well as better treatment approaches are all being discussed in hopes of some real inroads being made in this field in the near future. 

An End In Sight for C Difficile? 

In 2017, the Infectious Disease Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) published their updated clinical practice guidelines giving first-line therapy designation to vancomycin or fidaxomicin for all C difficile infections, thus supplanting metronidazole as the indicated therapy of choice.

Metronidazole was first discovered in the 1950s and has been indicated for a number of medical conditions and uses through the years including bacterial vaginosis, trichomoniasis, giardiasis, dracunculus, C difficile, E histolytica, preterm births, hypoxic radiosensitizer, and perioral dermatitis.

The change in the IDSA/SHEA guidelines did not mean metronidazole could not be indicated for use anymore. In fact, the guidelines said it can be used in settings where vancomycin or fidaxomicin might not be available. The drug is readily accessible internationally, and still has value in locations overseas.

Of course, cost is also a major factor in prescribing practices for metronidazole as the therapy is cost-effective. 

Wiep Klaas Smits, PhD, Department of Medical Microbiology, Leiden University Medical Center, says the change is a transitional process and still see value in the metronidazole. Smits believes clinicians should follow the guidelines, but knows costs, therapy availability, and patient profiles, all play roles in make decisions in prescribing.

“We should not expect people to stop using metronidazole from one day to the other because the guidelines changed,” Smits said. “It is important to keep in mind which patient groups this drug still might be effective.”

Smits will presenting his session at 12:25pm today, Metronidazole For the Treatment of C. difficile Infections: On the Way Out? today at the 

His research team investigated plasmid resistance using metronidazole in longitude studies, and although not widely seen, it is something to be aware of.

“We don’t routinely test for antimicrobial susceptibility against metronidazole,” Smits said.

spoke with Smits about his presentation, circumstances where metronidazole might be indicated, and some insights regarding the new research on plasmid resistance.

Although no longer indicated as a first-line therapy, metronidazole still has therapeutic benefits and can serve patients in certain settings and circumstances.

Is There Still Value in Prescribing Metronidazole for C Difficile Treatment?

. The first day of the conference concluded this afternoon, but 

 highlighted some of the presentations from throughout the day.

High school juniors Emma Brashear and Layla Ouldnouri have been researching 

infection (CDI) for over 2 years, and identified its invisible spores as one of the greatest challenges in preventing CDI.

 spores visible under ultraviolet light and thus easier to clean. Germinating 

 spores release the chemical compound dipicolinic acid, which illuminates under UV light when combined with terbium chloride.

The presenters highlighted the importance of their research, as 

infections cost $8.2 billion a year and cause more deaths each year than drunk driving and HIV combined.

"Microbiome Therapeutics in 2021: Almost there for C difficile!"

Sahil Khanna, MD, Professor of Medicine in the Mayo Clinic Division of Gastroenterology and Hepatology gave this presentation. He described recurring 

infections (CDI) as one of the greatest problems in modern medicine.

Khanna called microbiota restoration the “holy grail” for managing recurrent, and cited it as being over 85% effective at treating recurrent CDI. Additionally, microbiota restoration is superior to oral vancomycin and has fewer recipient contraindications.

Fecal Microbial Transplant (FMT) is also safe and effective for recurrent CDI. FMT practices are heterogeneous, though donor FMT is superior to autologous FMT.

When treating CDI, Khanna also advocated for eliminating modifiable risk factors, such as PPIs, hospitalization, sick contacts, and 

Khanna called standardized microbiota restoration “the future,” citing positive data from RBX2660 phase 3, SER-109 phase 3, CP101 phase 2, RBX7455 phase 2, and VE303 phase 2.

Introduction to Microbiota and Microbiota Restoration for Recurrent 

Presented by Ken Blount, Chief Scientific Officer of Rebiotix, this research also focused on recurrent CDI. Blount detailed the various ways each person’s complex and diverse community of microbes influence health.

Antibiotics disrupt a person’s normal bacterial microbiome, leading to CDI and recurrent CDI. The goal of investigational live biotherapeutics is to restore healthy microbiota and reduce recurrent CDI.

Blount cited RBX2660 and RBX7455, the same clinical trials as Khanna, as evidence of restoring microbiota and metabolite compositions to fight CDI.

CP101, an Investigational Orally Administered Microbiome Therapeutic Designed to Prevent Recurrent CDI

The final presentation of the first day of the conference was given by Shrish Bedree, MD, PhD, Medical Director and Head of Clinical Microbiome Science at Finch Therapeutics.

Bedree highlighted that recurrent CDI is an unmet medical need, and a significant burden on the healthcare system, noting that Finch is the only company with complete and targeted approaches for developing microbiome therapeutics.

CP101 is an orally administered investigational microbiome therapeutic that offers a complete microbial community. One administration of CP101 resulted in a rapid and sustained increase of microbiome diversity in Finch’s PRISM3 trial.

CP101 met its primary efficacy endpoint in PRISM3, and demonstrated statistically significant prevention of recurrent CDI. By week 8, CP101 achieved 33.8% relative risk reduction for CDI recurrence. There were no treatment-related serious adverse events reported for the CP101 arm.

Highlights from some of this afternoon's presenters at the 9th Annual International C diff Conference & Health Expo.

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