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1rem

“Usually for antibiotic awareness you have a week,” said Dr. Teena Chopra, “But for 

a whole month has been dedicated, for a reason.”

Awareness Month and Antimicrobial Awareness Week. As Chopra explains, too often the people most affected by a lack of vigilance in these areas already experience marginalization and discrimination.

“We are all global citizens, and having that uniform, consistent health care for all is where we need to move toward,” said Chopra.

Teena Chopra, MD, MPH is the Corporate Medical Director of Hospital Epidemiology at Detroit Medical Center, as well as a professor at the Wayne State University School of Medicine.

Chopra credits several mentors as inspiring her to specialize in infectious disease. Living and working in Detroit, MI, she has seen firsthand how infectious diseases can ravage underserved populations, moving her to practice where she’s most needed.

causes an estimated half a million infections a year and over a billion dollars in expenses in the US alone.

The Centers for Disease Control and Prevention (CDC) classifies 

However, until the disease touches their lives, the general public is largely unaware of its prevalence or even what 

 is. “We, as the health care community, need to raise more awareness for 

Listen in as Chopra discusses treatment regimens for 

 infection (CDI), as well as the populations disproportionately affected by this debilitating disease.

Missed Episode 6 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: 

Dr. Teena Chopra discusses the global need to do more to prevent healthcare-associated infections like C difficile in vulnerable patient populations.

C difficile, Antimicrobials, and the Patients Most Affected

Here is a recap of the latest happenings during C diff awareness month.

The Latest in Clostridioides difficile Research and News

In recognition of C difficile Awareness Month this November, the CDC's 2023 HAI Progress Report highlights continued progress in reducing CDIs across US healthcare settings.

Progress in Reducing C difficile Infections Highlights Key Achievements During C diff Awareness Month

Reduction of in-hospital rate of C difficile infection from 11% to 4%, with no increased risk of infection following treatment.

Oral Vancomycin Reduces CDI by 64% in Stem Cell Transplant Patients

This week, food recalls due to Listeria monocytogenes contamination and, a study comparing treatments for recurrent C difficile infections underscore the need for further research, policy adjustments, and more.




Head-to-Head Comparison of Treatments for Recurrent C difficile Infection

 Paul Feuerstadt, MD, FACG, AGAF, discusses what the data says as well as offers insights about what patients can expect and medical peer-to-peer information about the procedure. 

Two Years FDA Approved, Rebyota Continues to Show Efficacy and Safety

It has been 2 years this month since fecal microbiota, live – jslm (Rebyota) was FDA approved for the indication of recurrent 

 treatment in individuals 18 years of age and older, following antibiotic treatment for recurrent 

New data was released at this year’s ID Week showing its continued efficacy and safety 2 years after the approval. Ferring Pharmaceuticals announced results of its outpatient real-world study using Rebyota. 

In one of the analysis, investigators reviewed the medical records of 64 adult patients from 32 physician offices nationally who received Rebyota from February 2023 to March 2024. In total, 59 patients completed the 8-week follow-up period, of which 75% (n=44) had no CDI recurrence. There were no adverse events reported with treatment aside from minor leakage during administration in 4 patients (6.2%).

Participants in the analysis had a median age of 75 years and were predominantly female (65.6%). Patients had multiple comorbidities (Charlson score 4.5) and 59.4% had 2 or more rCDI risk factors, the most common being age, 65 years or older (75%), and concurrent use of gastric acid suppressants (59.4%). The median number of prior CDI episodes was 3. Fidaxomicin (57.8%) was the most utilized standard-of-care antibiotic for treatment of CDI prior to Rebyota administration.

Additionally there has been other data being released from the PUNCH CD3 trial.

“The open label study data that was published earlier in 2024, which was the largest study that looked at live biotherapeutic products, looked at 697 total patients, so a massive group expanding upon the PUNCH CD3 trial—the randomized control trial that had a placebo arm within this open label study,” said Paul Feuerstadt, MD, FACG, AGAF an associate clinical professor of medicine at the Yale School of Medicine. “Patients with IBS are going to show up in a provider's office with their current 

. Patients with ulcerative colitis and Crohn's disease are also going to show up in providers offices' with 

 so how does this work in a real world type scenario? And across those 697 patients, they found an efficacy of 73.8% further validating the randomized control trial from phase 3. And of those 73.8%, 91% remained responsive at 6 months. So in a real world, formalized study setting, we see very, very encouraging data.”

Feuerstadt also says in his conversations with patients he explains the differences from taking antibiotics and getting this treatment. 

“If we explain it appropriately, the patients will understand that the antibiotic controls the phase that causes symptoms, but that spore phase, the phase that remains in their system after the antibiotics that requires a healthy, diverse microbiota, and that regrowth of the microbiota without supplementation causes a recurrence. Therefore, if you're putting the microorganisms into the place where the infection is, you're preventing that recurrence. So patients can wrap their head around that concept and understand how you're treating the entire infection and how you're shutting down that cycle of recurrence. And that clicks in their head, where they have that aha moment,” Feuerstadt said.

For those not familiar with Rebyota, it is a live biotherapeutic product (LBP) that is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes, including 

. Rebyota is delivered directly to the gut microbiome and is administered by a healthcare professional in 1 visit.

. Real-World Effectiveness of Fecal Microbiota, live-jslm for the Prevention of Recurrent Clostridioides difficile Infection. Poster #220 presented at IDWeek 2024. October 16-19, 2024. Los Angeles, CA.



Paul Feuerstadt, MD, FACG, AGAF, discusses what the data says as well as offers insights about what patients can expect and medical peer-to-peer information about the procedure. 

Two Years After its FDA Approval, Rebyota Continues to Show Efficacy and Safety

The country’s largest fecal distributor, OpenBiome, could be prevented from offering the product next year if the FDA does not approve the product 

Due to FDA Policy Change, Fecal Microbiota Transplants are in a Tenuous Position

This fall, there has been some legal limbo going on at the FDA as it pertains to deciding if the federal agency should restrict the nonprofit company, OpenBiome, from continuing to distribute its fecal products for use in fecal microbiota transplants (FMT). This procedure has been a life-saving treatment for both adult and pediatric patients suffering from fulminant 

Prior to this fall, the FDA had allowed the distribution of the company’s fecal products under enforcement discretion for many years.

 However, the FDA changed its position creating an uneasy, untenable position for the future of FMT—at least in the short term.

Without OpenBiome’s ability to distribute their product, many patients might not have immediate access to FMT, and this is not an ideal situation considering the severity of infection for patients with fulminant 

, including the possibility it could cause death.

However, OpenBiome and another stakeholder, the 

 patient advocacy organization, the Peggy Lillis Foundation (PLF), have both pointed out the FDA has been open in listening to the needs of 

 patients and the community in allowing for the fecal products to be distributed while they try to find a more permanent solution.

“We are thankful to the FDA for listening to the patient and clinician communities and prevailing evidence and making this decision to prioritize patient care. As part of this guidance, we are submitting an [investigational new drug] IND application to the FDA by November 30th,” OpenBiome wrote in a statement on their website.

Christian Lillis, the CEO of PLF, believes the FDA policy change was more about unexpected consequences, and that the federal agency did not foresee this issue arising.

"I really think that this was unintended, and I'm glad that they [the FDA] listened to us and have come up with—at least a solution in the interim—that we can hopefully work together,” said Lillis.

The FDA has extended the deadline for OpenBiome to continue distributing their product through the end of this year, while they prepare their IND application.

Beginning in September and lasting through the end of October, many were concerned that OpenBiome, the country’s largest distributor of fecal microbiota transplant (FMT) products might be forced to stop altogether.

OpenBiome noted that it was only going to continue offering the products through October 31 in light of the fact the federal government said it would need to review the IND.

To be clear, these traditional FMT differ from the newer 

 that have been FDA approved over the last 2 years. LBP have been indicated for patients with recurrent 

, and not the other aforementioned groups. These newer modalities have been shown to be efficacious and safe.

Lillis and PLF remain what he calls “treatment agnostic” to the existing modalities.

“We need to be clear from the jump that the Peggy Lillis Foundation doesn't endorse or recommend any particular treatment,” Lillis said. “That decision is best made between a patient and their doctor, but what we do want is as many options to treat this infection as possible. And that's why we also need to maintain access to traditional FMT and it's really for a particular subset of patients.”

References
1. Enforcement Discretion for Investigational FMT Extended for Severe and Fulminant CDI. Openbiome statement. Accessed November 13, 2024.
https://openbiome.org/fmt-distribution-through-december-31/

The country’s largest fecal distributor, OpenBiome, could be prevented from offering the product next year if the FDA does not approve the product used for fecal microbiota transplants  to treat fulminant C difficile.   

Due to FDA Policy Change, Fecal Microbiota Transplants Are in a Tenuous Position

The STOP-CDI intervention presented by Matthew J Ziegler, MD MSCE revealed using prophylactic enteral vancomycin, significantly reduced hospital-onset C difficile infections  among immunocompromised patients.

Targeted Prophylaxis Reduces Hospital-Onset C. difficile Infections in High-Risk Patients

Patients undergoing immunosuppression for cancer treatment and transplantation are at the highest risk for developing hospital-onset 

 infections (HO-CDI). STOP-CDI investigated a prophylactic enteral vancomycin intervention aimed at reducing HO-CDI rates in high-risk hospitalized patients. The STOP-CDI intervention was found to effectively reduce HO-CDI rates, length of stay, and associated symptoms within this vulnerable population.

Matthew J Ziegler, MD MSCE, assistant professor of medicine at UPenn, presented the STOP-CDI trial results at IDWeek and discussed key findings on screening and targeted prophylaxis for CDI, and whether they challenge and/or support current clinical practices. “The key finding of our research was that among the patients who were screened, there was a very low rate of HO-CDI, less than 1%, compared to our control group, which had roughly 5.6% after waiting for the same diseases. We found that this STOP intervention was very successful at reducing HO-CDI, which contrasts with common clinical and infection control practices.”

From November 2021 to December 2023, 692 patients were screened for 

, with 11% colonized. The intervention group had lower odds of HO-CDI compared to matched controls, with a number needed to screen 31. Notable reductions in 90-day HO-CDI rates, stool output, and length of stay were observed, while no differences in vancomycin-resistant Enterococcus (VRE) infections or mortality were noted.

Ziegler discussed the implications for specific patient populations at higher risk for CDI, “When we did subgroup analyses of our research and looked at the relative benefit in solid organ transplant versus oncology patients, we saw a pretty stark difference. Our oncology patients historically had roughly a 7.5% rate of HO-CDI, and that went down to 1% in our intervention, showing a large difference and significant benefit from the intervention.”

Patients undergoing solid organ transplants, autologous stem cell transplants, CAR-T therapy, or leukemia treatment were screened for 

 colonization. Those who tested positive received oral vancomycin prophylaxis for 10 days or until discharge. Outcomes were compared to concurrent and historical controls, with the primary outcome being HO-CDI and secondary outcomes including 90-day CDI rates, stool output, length of stay, VRE infections, and mortality.

“On the other hand, our solid organ transplant patients were enrolled during their index admission for organ transplantation, and our historical rate of HO-CDI in that group is only 1%. While that dropped from 1% to zero, that’s a much smaller absolute difference. We thought that would be a group likely to benefit, but it turns out that this group seems to be at lower risk of transitioning from colonization to an infection state during that specific time period,” Ziegler said.

Ziegler discussed the integration of screening and prophylactic measures for CDI evolving in clinical settings, considering emerging guidelines and antibiotic stewardship initiatives: “I think the uptake of this practice, clinically or more broadly, requires some additional research to identify other patient populations that are at high risk. It’s possible that there are other patient populations where this intervention may also be useful, but it’s also possible that this research intervention, or the STOP intervention, may not be beneficial for all hospitalized patients.”

Ziegler concludes, “Many antibiotic stewardship interventions focus on giving antibiotics to patients who will benefit and trying to avoid them in patients who won’t. I think this targeted prophylaxis approach really falls in line with some of these tenets of antibiotic stewardship.” Future research will explore how targeted screening and prophylaxis can reduce 

 transmission in various units and its effectiveness in other patient populations.

Ziegler M, et. al. Screening and Targeted Prophylaxis for 

Infection: STOP-CDI. Presentation #203 presented at IDWeek 2024. October 16-19, 2024. Los Angeles, CA.

The STOP-CDI intervention presented by Matthew J.Ziegler, MD MSCE revealed using prophylactic enteral vancomycin, significantly reduced hospital-onset C difficile infections  among immunocompromised patients.

Conferences

Targeted Prophylaxis Reduces Hospital-Onset C difficile Infections in High-Risk Patients

Peggy Lillis Foundation CEO Christian Lillis believes patients need a seat at the table

Getting Patients involved in C diff Treatment Guidelines

 organization, The Peggy Lillis Foundation (PLF) has had a big year. The patient advocacy group helped in getting a bill into Congress. Their work in advocacy and having conversations with Congresswoman Yvette Clark (D-NY) and her staff, led to Clark introducing the legislation, the Peggy Lillis 

 Inclusion Act, into the House of Representatives this past summer. The act calls for 

nationally notifiable infectious disease and condition

PLF was instrumental in getting the bill introduced. “

 is a disease that affects more than half a million Americans. It leads to around 30,000 deaths, and yet most Americans haven't heard of it,” PLF CEO Christian Lillis said. “And if you have an 

 outbreak in lettuce, everyone knows about it. Everyone knows as a recall, everyone knows to wash their food. And yet we don't have that same kind of surveillance or alert around a contagious disease. And so our feeling is if we were counting all the cases, we would understand that it's probably bigger than half a million people, and that it's probably more than 30,000 deaths. And then from there, we could start to really understand what it's going to take to change course and to really resolve it.”

As part of its governmental advocacy, PLF has a Lobby Day in Washington DC every year where they speak to Congressional representatives and their aides. They bring along PLF board members and people who have had C diff and are involved in the organization. And while he is grateful for the people who are involved with PLF and the greater fight against C diff, he acknowledges they are a small organization and he would like to see more people participate in advocacy. 

“Another thing that we're really focused on is how do we continue to get people who have survived 

 and who have maybe benefited from these new products to become ambassadors around the disease? We know it can be embarrassing; we know it's not the sexiest thing to talk about; but until we get more and more people to know that it exists, people can't engage in prevention. They can't advocate for themselves and for others.”

He also says this is important so that patients and former patients can get involved in treatment guidelines.

“We're definitely focused on the fact we need to have more of a patient voice in guidelines, the AGA guidelines, the IDSA guidelines—they don't have patients on those committees,” Lillis said. “As somebody who has been working with patients for 15 years, when I read the guidelines, I can tell that a patient hasn't seen them. And this isn't so much about the science, it's about the delivery.

In addition, PLF will have their annual gala next month during 

 awareness month and honor both people who have had C diff, and medical professionals.

Next year PLF is going into a noted anniversary year and plan to revolve a significant amount of their plans into it. "We are going into 2025 celebrating our 15th anniversary year, and so we really want to look back at what we've accomplished, look forward a bit towards to what still remains to be done, but also really celebrate all of the people, the sponsors, the press—everyone who has helped us to raise awareness of this disease, to empower people that have this disease, to empower their families, and to push for new treatment."

Peggy Lillis Foundation CEO Christian Lillis believes patients need a seat at the table so he is advocating for past patients to become ambassadors to be a voice to help shape treatment and also continue to raise awareness about the infection.   

Getting Patients Involved in C diff Advocacy, Treatment Guidelines

Maryann Webb’s harrowing personal experience with C diff, along with her professional work with federal government agencies has prepared her for a life in advocacy with the Peggy Lillis Foundation

Advocating for Better Regulatory Rules and Standard of Care for C difficile

Make no mistake; Maryann Webb is a fighter. She has battled both 

 and breast cancer simultaneously. During her sickest time, she felt her organs shutting down, and she was getting her affairs in order because she thought she was going to die.

“I was just wasting away. I could feel myself dying…I really just didn't know what was going on, but I knew that I was nearing the end of my life, so I carefully, without anyone noticing, I got rid of a lot of my possessions, so that my daughter and my husband wouldn't have to deal with that,” Webb said.

In the midst of her severe infection, she also developed breast cancer and needed a double mastectomy.

 continued on. She was dealing with the infection between 2015 and 2018, and finally, after suffering for 3 years, she got some help from her family. “At the very last minute, my sister-in-law put me in touch with a doctor who did fecal microbiota transplants (FMT)…And when I did receive the FMT, about 8 hours after it, I knew that the infection was gone and from that moment on, I just got better,” Webb said.

After her health transformation, Webb began getting involved in advocacy in 2019 including working with the 

 She is now a member of the PLF's Board of Directors, and will be presented with the Advocate Award at the organization's 15th Annual Changing the Odds Gala this November.

 inspired her to get involved and help others suffering from the infection. “I'm extremely honored. The reason that I do this advocacy work is I know what it's like as a survivor to have suffered through this infection,” Webb said. “I know how isolating and dehumanizing it is, and I know the stigma that's attached to it. I understand the pain and the hopelessness that people feel when they're going through this. So, once I recovered, it just seemed incumbent upon me to be able to reach out to the people who are still in that bed and offer them the hope that I didn't have, and the support that I didn't have, and try to create that kind of community for them.”

It is this last part she feels has not been recognized and people suffering from the infection need support.

“If you know someone who has C diff, please offer them any kind of support and assistance that you can and also encourage them to get some mental health as part of their treatment, because it's a very, very trying, isolating disease,” Webb said.

As part of her advocacy, she would like to see FMTs become more accessible. After years of suffering, she was able to get the procedure.

Maryann Webb’s harrowing, personal experience with C diff, along with her professional work with federal agencies has prepared her for a life in advocacy with the Peggy Lillis Foundation. She wants to see the fecal microbiota transplant become more accessible and is working with Congress to make the infection a notifiable infectious disease.

C. Difficile

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