Tag Archives: Healthcare-Associated Infections

Seres Therapeutics, Inc., A Leading Microbiome Therapeutics Company, Announced Positive Results From the Phase 1b/2 Study of SER-109 In Recurrent Clostridium difficile infections (CDI)




“The impressive level of efficacy observed with SER-109 treatment is striking when compared with the high rate of recurrence expected in this population,” said Dr. Stuart H. Cohen, MD, Chief, Division of Infectious Diseases, University of California, Davis. “These results demonstrate the potential of SER-109 to effectively treat recurrent CDI. With current treatment approaches having significant limitations, SER-109 has the potential to fundamentally change the management of this urgent health issue.”


Background. Patients with recurrent Clostridium difficile infection (CDI) have a ≥60% risk of relapse, as conventional therapies do not address the underlying gastrointestinal dysbiosis. This exploratory study evaluated the safety and efficacy of bacterial spores for preventing recurrent CDI.

Methods.  Stool specimens from healthy donors were treated with ethanol to eliminate pathogens. The resulting spores were fractionated and encapsulated for oral delivery as SER-109. Following their response to standard-of-care antibiotics, patients in cohort 1 were treated with SER-109 on 2 consecutive days (geometric mean dose, 1.7 × 109 spores), and those in cohort 2 were treated on 1 day (geometric mean dose, 1.1 × 108 spores). The primary efficacy end point was absence of C. difficile–positive diarrhea during an 8-week follow-up period. Microbiome alterations were assessed.

Results.  Thirty patients (median age, 66.5 years; 67% female) were enrolled, and 26 (86.7%) met the primary efficacy end point. Three patients with early, self-limiting C. difficile–positive diarrhea did not require antibiotics and tested negative for C. difficile at 8 weeks; thus, 96.7% (29 of 30) achieved clinical resolution. In parallel, gut microbiota rapidly diversified, with durable engraftment of spores and no outgrowth of non–spore-forming bacteria found after SER-109 treatment. Adverse events included mild diarrhea, abdominal pain, and nausea.

Conclusions.  SER-109 successfully prevented CDI and had a favorable safety profile, supporting a novel microbiome-based intervention as a potential therapy for recurrent CDI.


Clostridium difficile infection (CDI) and its attendant complications, including diarrhea, pseudomembranous colitis, and toxic megacolon, are associated with an estimated 29 000 annual deaths in the United States and is recognized by the Centers for Disease Control and Prevention as an urgent public health priority [1]. Antibiotic exposure is the leading risk factor for CDI, and the risk of recurrent disease is increased among elderly patients and following antibiotic reexposure. Antibiotic therapy for recurrent CDI contributes to persistent disruption of the gut microbiome, which is the first-line defense against colonization and infection by pathogens, including C. difficile [25]. The risk of recurrence increases to >60% following a second episode [3, 6, 7].

Research has focused on the potential role that the human microbiome plays in health and disease. In 2008, the National Institutes of Health supported the creation of the Human Microbiome Project to characterize the species composition and function of the healthy microbiome. In the gut, the 2 dominant phyla are Firmicutes (ie, gram-positive organisms, including Bacilli and Clostridia) and Bacteroidetes (ie, gram-negative anaerobes, including Bacteroides, Parabacteroides, and Prevotella) [8, 9]. In contrast, gram-negative Enterobacteriaceae, such as Escherichia coli, make up only a fraction of the healthy microbiome [8]. There is also significant intersubject variability at both the genus and species level, suggesting that the bacterial communities in any one individual are unique, mirroring the complex interplay of diet, host genetics, immune response, and microbial coadaptation. Despite this variation, there are common core species found in a majority of healthy individuals, and metabolic pathways are preserved due to functional redundancy [10]. Thus, a wide range of microbiomes defines a healthy state.

In states of disease, there are also broad patterns that define gut dysbiosis, such as a loss of microbial diversity and increasing representation of gram-negative facultative anaerobes, such as Enterobacteriaceae [11, 12]. Antibiotic-induced dysbiosis underlies colonization and invasion by C. difficile, while repair of the microbiome, through fecal microbiota transplantation (FMT), is associated with efficacy rates of 81%–90% for those with recurrent CDI [1316]. FMT involves transferring minimally processed, uncharacterized fecal material from a healthy donor to a recipient [17].

FMT administration is often invasive and requires donor screening and stool preparation. Despite donor screening, stool preparations for FMT have the potential to transmit infections due to pathogens that are present at times outside the period of detectability or for which diagnostic tests are unavailable; there is also the possibility of unwitting transmission of emerging pathogens that have not been identified to date [18, 19]. While there have been recent reports of stool delivered via oral encapsulated FMT or stool enemas, the data demonstrate first-dose efficacy of approximately 52%–70%, which is significantly lower than that for other modes of administration, such as colonoscopy [14, 20, 21]. In recognition of FMT as an experimental biologic, the Food and Drug Administration issued guidance that this intervention should only be used for prevention of recurrent CDI and after receipt of informed consent. An alternative approach for achieving improved safety and convenience with comparable efficacy is urgently needed [22].

SER-109 is composed of approximately 50 species of Firmicutes spores derived from stool specimens from healthy donors. After demonstrating the preclinical efficacy of SER-109 in rodent CDI models, we formulated it for oral delivery in humans based on the hypothesis that spore-forming organisms would compete metabolically with C. difficile for essential nutrients and/or bile acids [2327]. In addition, spore purification with ethanol reduces the risk of transmission of other potential pathogens [28]. This initial study was designed to evaluate the efficacy and safety profile of SER-109 for CDI prevention in patients with recurrent infections and to measure alterations in the gut microbiota.


Study Design

This open-label, single-arm, descending-dose study evaluated the safety, efficacy, and engraftment of SER-109 formulated for oral delivery. The study was sponsored by Seres Therapeutics and conducted at 4 US medical centers: Massachusetts General Hospital (Boston, Massachusetts), Mayo Clinic (Rochester, Minnesota), Miriam Hospital (Providence, Rhode Island), and Emory University Hospital (Atlanta, Georgia). The protocol was developed by investigators at Seres Therapeutics and authors of the current study (E. L. H., D. S. P., and S. K.) and was approved by the institutional review boards of the participating medical centers.

Study Population

Eligible patients were 18–90 years old and had ≥3 laboratory-confirmed CDI episodes in the previous 12 months, had a life expectancy of ≥3 months, and gave informed consent to receive this donor-derived product. Patients were excluded for a history of acute leukemia; hematopoietic stem cell transplantation, chemotherapy within 2 months and an absolute neutrophil count of <1000 neutrophils/mm3, a history of inflammatory or irritable bowel disease, colectomy, cirrhosis, pregnancy/lactation, severe acute illness unrelated to CDI, antibiotic exposure for a non-CDI indication within 14 days of screening, or prior FMT.

Eligible patients had a clinical response to antibiotic therapy for their current CDI episode immediately prior to dosing and were neither anticipated to require admission to an intensive care unit nor expected to need antibiotics within 6 weeks following study entry.

Screening of Donors

Seven adult donors of stool specimens gave informed consent, underwent a complete medical history and laboratory assessment, and were screened for blood-borne and fecal pathogens, consistent with published protocols [29, 30]. Donors were excluded for being older than 50 years, having a body mass index (BMI; calculated as the weight in kilograms divided by the height in meters squared) of >25, engaging in high-risk behaviors as per a modified American Association of Blood Banks blood donor questionnaire [31], having a history of acute/chronic gastrointestinal disorders, or using antibiotics (in the previous 6 months), immunosuppressive/antineoplastic agents, or cigarettes (Supplementary Materials).

Preparation of SER-109

SER-109 comprises Firmicutes spores fractionated from stool specimens obtained from healthy donors. Donor stool specimens were processed separately to make unique batches of SER-109. Upon collection, stool specimens were frozen at −80°C. Approximately 150 g was suspended and homogenized in normal saline and filtered through mesh screens. The slurry was centrifuged, and supernatant containing bacterial cells and spores was combined with 100% ethanol to 50% (wt/wt) and incubated at room temperature for 1 hour to reduce risk of pathogen transmission to the recipient [28]. The supernatant was pelleted by centrifugation, washed with saline to remove ethanol, resuspended with sterile glycerol, and filled into capsules (hypromellose DRcaps, Capsugel), which were stored at −80°C.

The product was characterized for spore concentration and absence of residual gram-negative bacteria. Spore content was determined by measuring the dipicolinic acid (DPA) content and normalizing against the DPA content of known numbers of spores representing 3 commensal species [32]. The absence of residual gram-negative bacteria was confirmed by selective plating on MacConkey lactose agar and Bacteroides bile esculin agar. No vegetative microbes were found in any SER-109 preparation within the limit of assay detection (<30 colony-forming units/mL).

Treatment Protocol

Two days prior to dosing, patients discontinued antibiotics for CDI. One day prior to dosing, patients underwent a bowel preparation (to minimize residual antibiotic in the gastrointestinal tract), followed by overnight fasting. Two sites used a regimen of 300 mL of magnesium-citrate (one with Dulcolax), and 2 sites used polyethylene glycol.

Part 1 enrolled 15 patients who each received 30 capsules of SER-109 (observed dose of 15 capsules on day 0 and day 1). The dose of spores varied between 3 × 107 and 2 × 1010, based on natural variations in spore concentration among healthy donors. Based on initial efficacy, 15 additional patients were enrolled in part 2 and treated with SER-109 capsules containing a lower fixed dose of 1 × 108 spores (approximately 17-fold lower than the geometric mean dose administered in part 1 and 3-fold above the minimum dose shown to be effective). Depending on spore content, patients received an observed dose of 1–12 capsules on day 0.

Any patient whose diarrhea recurred between 1 and 8 weeks was eligible for another dose of SER-109, based on data from the conventional FMT literature showing efficacy of a second dose [13, 14]. If a patient elected to receive a second dose of SER-109, the time course of study events was restarted concurrent with the second dose of SER-109.

Adverse events and recurrence of CDI symptoms were monitored through phone calls (on day 4 and weeks 1, 2, and 4) and in-clinic visits (on weeks 8 and 24). Patients were asked to provide a stool sample on day 4 and on weeks 1, 2, 4, 8, and 24 after treatment for genomic and culture-based analysis.

Clinical Outcomes

The primary end point was prevention of recurrent CDI during the 8-week follow-up after SER-109. CDI recurrence was defined as a composite end point of >3 unformed bowel movements in a 24-hour period and laboratory confirmation of C. difficile in the stool. Safety was evaluated by monitoring adverse events and assessing changes in laboratory values, vital signs, and physical examination findings over a 24-week period after dosing.

Alterations in Gut Microbiota Composition

The impact of SER-109 on gut microbiota was determined by examining stool samples before and after treatment for (1) engraftment by spore-forming species and (2) augmentation (outgrowth) of commensal bacteria not found in SER-109. Alterations in composition were measured by 16S ribosomal RNA (rRNA) genomic and culture-based analysis of patient fecal samples (Supplementary Materials). Engraftment was defined by newly detected spore formers in the patient after treatment, which were present in SER-109 but not detectable in the patient before treatment. Augmented bacteria were defined as non–SER-109 organisms whose levels increased at least 10-fold after treatment.


Patient Population

Thirty patients were enrolled after therapeutic response to appropriate CDI antibiotics (ie, vancomycin [n = 23], fidaxomicin [n = 5], metronidazole [n = 1], and rifaximin [n = 1]) was documented (Table 1). Patients had a median age of 66.5 years (range, 22–88 years), and the majority of subjects (67%) were female. The median time from the initial C. difficile diagnosis to the most recent recurrence was 23.1 weeks in cohort 1 and 34.3 weeks in cohort 2. In the overall study population, the median number of CDI recurrences was 3 (range, 2–6 recurrences). Infecting C. difficile strains were identified in 10 patients and included types BI, Y, and DH (Supplementary Table 1).

View this table:

Table 1.

Patient Demographic Characteristics, by Cohort

Complete blood counts and a chemistry panel (including liver function tests and analysis of albumin and creatinine levels) were performed at week 8 (for 27 of 30 patients) and at week 24 or early termination for 20 of 30 patients. No significant changes in laboratory findings were observed, with the exception of those for 1 patient, who had an elevated white blood cell count at week 8 at the time of diagnosis of a urinary tract infection.

Clinical Outcomes

Of the 30 patients who received SER-109, 26 (86.7%) achieved the primary end point of no C. difficile–positive diarrhea up to 8 weeks following dosing, with similar outcomes in both dosing cohorts (Figure 1). Of the patients who met the primary end point, 1 required a second dose of SER-109 for recurrence of C. difficile–positive diarrhea on day 26, as per protocol. Four patients who did not meet the primary end point had early onset of symptoms at days 3, 5, 7, and 9 after administration of SER-109 and laboratory confirmation of C. difficile. One of these patients declined a second SER-109 dose and chose not to continue participating in the study. Notably, the other 3 patients were determined by their primary investigator to be recovering from a self-limiting diarrheal episode at the time of stool submission for C. difficile testing. In each case, the investigators advised the patients to refrain from antibiotic use, and all symptoms resolved without any therapeutic intervention; stool samples from these 3 patients were negative for C. difficile carriage at 8 weeks, using a sensitive nucleic acid amplification test for detection of toxins A and B. Thus, 29 of 30 patients (96.7%) achieved clinical resolution of recurrent CDI following SER-109 administration.






C. difficile Infection (CDI) C Diff Foundation Opens a New Avenue – C. diff. Nationwide Community Support Program

The C Diff Foundation introduces the  C. diff. Nationwide Community Support (CDNCS) program beginning in November  for patients, families, survivors and for anyone seeking information and support.

C. difficile (C. diff.) infections caused almost half a million infections among patients in the United States in a single year, according to a 2015 study by the Centers for Disease Control and Prevention (CDC).

In addition, an estimated 15,000 deaths are directly attributable to C. difficile infections, making them a substantial cause of infectious disease death in the United States. [i].

As of 2015, there is an absence of professional C. diff. (CDI) support groups in America. The          C Diff Foundation has pioneered a collaborative plan and developed support groups in a variety of availability and locations to meet the needs of individuals seeking C. diff. information and support.

“We found it to be of the utmost importance to implement this new pathway for support and healing after speaking with numerous patients, family members, and fellow-C. diff. survivors,”

We now speak for the thousands of patients within the United States who, each year, are diagnosed with a C. diff. infection. This growth, in part, reflects the value C. diff. support groups will provide, not only to patients, their spouses, and families who are living with and recovering from a C. diff. infection, but also to the countless number of individuals who will become more aware of a C. diff. infection, the importance of early detection, appropriate treatments, and environmental safety protocols. There will also be Bereavement support group sessions for   C. diff. survivors mourning the loss of loved ones following their death from C. diff. infection involvement.

Beginning November 2015 the CDNCS groups will be available to all individuals via: Teleconferencing with some groups advancing and adding computer application programs in 2016. CDNCS groups will provide support and information  to 15 participants in each session.

The CDNCS program sessions will be hosted via: Teleconferencing with leaders hosting from Maryland, Florida, Missouri, Colorado, Ohio, and Oregon.

The Colorado CDNCS group is offered at a public venue and will be hosted in Arvada, Colo. every third Tuesday of each month, beginning November 17th. The Meeting will start at 5:30 p.m. and end at 7 p.m lead by a C Diff Foundation Volunteer Advocate and C. diff. survivor          Mr. Roy Poole.

To participate in any CDNCS group being offered during each month, all interested participants will be asked to register through the Nationwide Hot-Line (1-844-FOR-CDIF) or through the   website http://cdifffoundation.org/ where registered individuals will receive a reply e-mail containing support group access information.

  • The Support Registration Page  will be available on November 1st.

The C. diff. Nationwide Community Support group leaders will provide a menu of topics being shared each month on the C Diff Foundation’s website ranging from Financial Crisis Relief, Bereavement, Nutrition, Mental Health, to C. diff. infection updates and everyday life during and after being treated for a prolonged illness. Teleconference sessions will also host healthcare professional topic experts

There is evidence that people who attend support group meetings have a better understanding of the illness and their treatment choices. They also tend to experience less anxiety, develop a more positive outlook, and a better ability to cope and adapt to life during and after the treatment for C. diff.

There is a Purpose:

A diagnosis of a C. diff. infection is unexpected and almost always traumatic. As a result, it is not uncommon for newly diagnosed patients to experience a wide range of emotions including, confusion, bewilderment, anger, fear, panic, and denial. Many people find that just having an opportunity to talk with another person, who has experienced the same situation, to help alleviate some of the anxiety and distress they commonly experience.

Individuals also find that they benefit not only from the support they receive, but also from the sense of well-being they gain from helping others. It has been said “support is not something you do for others but rather something you do with others.”

“None of us can do this alone – all of us can do this together.”


Follow the C Diff Foundation on Twitter @cdiffFoundation #cdiff2015 and                                        Facebook https://www.facebook.com/CdiffFoundationRadio.

Note/citation: [i] http://www.cdc.gov/drugresistance/biggest_threats.html

Preventing Healthcare-Associated Infections (HAI’s) and the War On Superbugs

Many hospitals have made impressive strides in preventing health care-associated infections; some have seen a 70 percent reduction in the rate of bloodstream infections, thanks to safeguards such as checklists of steps to take before and during medical procedures and stepped-up hand-washing. But the problem continues to worsen. Now the White House has asked Congress for $1.2 billion to fund an effort to cut the rate of dangerous infections in half by 2020. The plan includes steps to prevent and slow the spread of infection, improve surveillance of resistant bugs, develop better diagnostic tests and new antibiotics and curb the misuse of currently available drugs – the main driver of drug resistance.

This is no fleeting crisis. Experts warn that the loss of antibiotics would roll back medical progress by 70 or 80 years. Without them, people could die of everyday dental abscesses and strep throat. Just inserting an IV could have lethal consequences. “Medical practice developed in a way that presumes the ability to treat infection in order to allow other things to be done like major surgery, cancer chemotherapy, transplants and joint replacement,” says James Johnson, senior associate director of the Infectious Disease Fellowship Program at the University of Minnesota in Minneapolis.

In terms of their power and importance, “almost nothing else in medicine comes close,” says Brad Spellberg, chief medical officer and professor of clinical medicine at the Los Angeles County and USC Medical Center. He is also the author of “Rising Plague: The Global Threat from Deadly Bacteria and Our Dwindling Arsenal to Fight Them.”

The trouble is that “any time we use antibiotics, we’re contributing to their future ineffectiveness,” Johnson says. It’s natural for an organism to eventually become resistant to that drug. And too often, bowing to the demands of patients, doctors prescribe antibiotics when they’re not needed; the drugs aren’t effective against viral illnesses.

Another problem: Because it takes time to determine precisely which organism is the culprit, doctors frequently prescribe “broad spectrum” antibiotics that work against a wide range of bacteria when a more targeted drug would do. “The consequence,” Johnson says, is that “we’re using our last-reserve antibiotics with increasing frequency.” The CDC estimates that at least 50 percent of antibiotic use in humans is unnecessary or inappropriate.

At the same time, 80 percent of antibiotics in the U.S. are used in livestock feed to prevent or control infection and promote growth, which fuels outbreaks of drug-resistant organisms such as Salmonella, E. coli and Campylobacter that spread through the environment. The end result: “There are patients in hospitals in the U.S. today suffering and dying from infections for which doctors have no antibiotics to give,” says Arjun Srinivasan, associate director for Healthcare Associated Infection Prevention Programs for the CDC. “They are completely resistant to all therapies.” Experts agree that no single intervention will solve the problem – and are exploring a number of needed solutions:

Under the president’s plan, hospitals would establish antibiotic stewardship programs to focus doctors on “prescribing the right antibiotic at the right time at the right dose for the right duration,” says Ann McIntyre, clinical associate professor in internal medicine at Nova Southeastern University and director of the infectious diseases fellowship program at Palmetto General Hospital in Florida. Only about half of hospitals currently have such programs. But the Centers for Medicare and Medicaid Services is expected to make them a requirement for eligibility for reimbursements by 2017. Typically led by a multidisciplinary team – infectious disease doctors, pharmacists, microbiologists or epidemiologists and nurses – stewardship programs involve keeping careful control over how the drugs are dispensed. They include such strategies as frequently reviewing patients’ status to make sure they still need an antibiotic, and if so, reassessing the drug, dosage and type of delivery (switching from IV to oral antibiotics, for instance, eliminates a potential source of additional infection), and restricting the use of certain broad spectrum antibiotics until an antibiotic expert weighs in. “Physicians are used to practicing for the patient in the moment and not having to think about all patients globally,” says Neil Fishman, an infectious disease specialist and chief patient safety officer at the University of Pennsylvania Health System. That, he says, has to change.


To read article in its entirety click on the link below:



“It Takes A Village” Re: Clostridium difficile (C.diff.) and Healthcare-Associated Infections, By Dr. Rosie D. Lyles, MD,MHA,MSc

“It Takes a Village”
By: Rosie D. Lyles, MD, MHA, MSc, Head of Clinical Affairs for Clorox Healthcare
September 21, 2015

With increasing rates of Clostridium difficile infections (CDI), C. difficile now rivals methicillin-resistance Staphylococcus aureus (MRSA) as the most common organism to cause healthcare-associated infections (HAIs) in the United States. (1) The prevalence of C. difficile infections has more than doubled in U.S. hospitals from 2000 to 2009 (2) and CDI is regarded as one of the serious, expensive, and potentially avoidable consequences of hospitalization. The cost of treating CDI in the hospital is $3427-$9960 (in 2012), and the cost of treating patients with recurrent CDI is $11,631, for a total cost of more than $1.2 billion annually in the United States. (3-4)

In June 2015, the White House spearheaded an executive call to action focused on implementing and improving antibiotic stewardship programs (ASPs) across the continuum of care (acute care facilities, outpatient clinics, doctors’ offices and long-term care facilities). The urgency around this issue stems from the increasing number of antibiotics prescribed, which subsequently breeds multi-drug resistant organisms (MDROs) like C. difficile. Unnecessary or excessive antibiotic use combined with poor infection control practices may increase the spread of C. difficile within a facility and across facilities when infected patients transfer, such as from a hospital to a nursing home. Increasing evidence suggests that contaminated surfaces in healthcare facilities play an important role in the transmission of several key pathogens including C. difficile, vancomycin – resistant enterococci (VRE), MRSA, Acinetobacter baumannii, and norovirus.

In order to reduce HAIs, all hands on deck are required to support a successful infection prevention strategy. In other words, “it takes a village.” Growing up, I remember hearing the phrase, “it takes a village to raise a child,” meaning there is a partnership within a community with several individuals playing a role in the maturation of a youth. Within a hospital, it’s a collaborative team across several departments that implements evidence-based protocols, continues to educate staff and patients, and maintains compliance of infection control strategies/approaches to reduce the risk of a broad range of infections, including CDI. From the C-suite (administrators and senior management) to direct healthcare providers (such as physicians, nurses, aides, and therapists) and environmental staff (EVS); everyone with direct or indirect contact with a patient’s care plays an essential role.

As a healthcare professional, it’s very important for hospitals to focus on the bigger picture when it comes to infection prevention strategy and control. Prioritizing infection control measures for just one or two pathogens of concern is insufficient. At the end of the day, one pathogen doesn’t trump another because patients don’t want an HAI from ANY pathogen! The horizontal approaches aim to reduce the risk of infections due to a broad array of pathogens through implementation of standardized practices that do not depend on patient-specific conditions:

• Proper hand hygiene
Hand hygiene practices in compliance with the Centers for Disease Control and Prevention (CDC) or World Health Organization (WHO) guidelines are a key component in preventing and controlling C. difficile, in addition to many other HAI-causing pathogens.
• Universal use of gloves or gloves and gowns
Donning the correct protective equipment minimizes contact with pathogens. It is also important to follow protocols for properly discarding this equipment.
• Universal decolonization (daily optimal bathing with chlorhexidine gluconate (CHG))
CHG bathing has been shown to decrease the bioburden of microorganisms on the patient, the environment, and the hands of healthcare personnel.
• Antimicrobial stewardship program
Ensuring every patient receives an antibiotic only when needed: the right agent, at the right dose, for the right duration.
• Evidence-based environmental cleaning and disinfection products
At a minimum, effective environmental cleaning involves using cleaners & disinfectants that are registered by the Environmental Protection Agency (EPA). Supplementing manual cleaning with new technology like ultraviolet (UV) light provides an extra layer of protection and the most comprehensive approach. UV has the highest-energy form that can inactivate dangerous and persistent pathogens by eradicating microorganism deoxyribonucleic acid (DNA) that may be left on surfaces, which can be missed with traditional cleaning. Finally, because C. difficile has been found in non-CDI patient rooms, using an EPA-registered sporicidal surface disinfectant to clean all patient rooms (daily and terminal) is great strategy to prevent the spread of the bacteria.

I had the pleasure of attending the CDC’s Environmental Hygiene for Ebola and Other Emerging Pathogens meeting on September 14, 2015, with attendees from academia, private industry, federal employees and health organizations, participated in a roundtable discussion on the research framework needed to determine the public health significance of non-critical environmental surface contamination and provide guidance to healthcare facilities about the methods to reduce the contamination of non-critical environmental surfaces reliably in order to improve patient safety. Every participant present at the meeting agreed that, due to the challenges/barriers that hospitals face with preventing HAIs (both from emerging pathogens and more common pathogens like C. difficile), it takes a village to successfully implement evidence-based protocols, continue to educate and maintain compliance with infection prevention protocols.


About Rosie D. Lyles, MD, MHA, MSc, Head of Clinical Affairs for Clorox Healthcare

Rosie D. Lyles, MD, MHA, MSc is the Head of Clinical Affairs for the Clorox Professional Products Company where she serves as a research fellow and primary medical science liaison for the healthcare business, supporting all scientific research as well as clinical and product intervention design and development.
Dr. Lyles previously served as a physician researcher and study director for multiple epidemiologic research initiatives in the Division of Infectious Diseases at the Cook County Health and Hospitals System, investigating healthcare-associated infections with a particular focus on the epidemiology and prevention of multidrug-resistant organisms and infections in intensive care units and in long-term acute care hospitals. She has directed numerous clinical studies and interventions for the Centers for Disease Control and Prevention (CDC) and the Chicago Antimicrobial Resistance and Infection Prevention Epicenter.
During her nine years as a study director and physician researcher at Hektoen Institute for Medical Research, Dr. Lyles’ work included CDC Epicenters Prevention program studies on bloodstream infections, Clostridium difficile infections and case-control studies of community-acquired Methicillin-resistant Staphylococcus aureus (MRSA). She also performed surveillance studies of Klebsiella pneumoniae carbapenemase (KPC) positive patients, examining universal contact isolation and patient skin antisepsis protocols to identify ways to optimize standard infection control measures.
Dr. Lyles received her medical degree from St. Matthew’s University School of Medicine and holds a Master of Health Service Administration from St. Joseph College. She also recently completed a Master of Science in Clinical Research and Translational Sciences through the University of Illinois at Chicago. She is an active member of the Association of Professionals in Infection Control and Epidemiology, the Infectious Disease Society of America, the Society for Healthcare Epidemiology of America and has served as a peer reviewer for the National Institutes of Health, New England Journal of Medicine, and American Journal of Infection Control.
1. Dubberke, ER, et al. Strategies to Prevent Clostridium difficile Infections in Acute Care Hospitals: 2014 Update. Infect Control Hosp Epidemiol. 2014, V35:S48-S65
2. Tabak et al., Predicting the Risk for Hospital-onset Clostridium difficile Infection (HO-CDI) at the Time if Inpatient Admission: HO-CDI Risk Score. Infect Control Hosp Epidemiol. 2015, 36: 6; 695-701
3. Magill, SS. et al. “Multistate Point-Prevalence Survey of Health Care-Associated Infections.” The New England Journal of Medicine 370.13 (2014): 1198–1208.
4. Dubberke, ER, and Olsen, MA. “Burden of Clostridium Difficile on the Healthcare System.” Clinical infectious diseases 55 Suppl. 2 (2012): S88–92.
5. Septimus, E., et al. “Approaches for preventing Healthcare-associated Infections: Go Long or Go Wide?” Infect Control Hosp Epidemiol. 2014. 35: 7; 797-801

Trinity Guardion Bed Protection System Proven To Reduce C. diff., A Healthcare-Associated Infection, By 50%


Trinity Guardion was selected by Xavier University’s Center for Innovation to present their Bed Protection System, which is proven to reduce a Hospital Acquired C.diff infection by 50%, at Healthovate! Summit on Thursday, June 11. The 2015

Xavier Center for Innovation (CFI) Healthovate! Summit is co-sponsored by Intel-GE Care Innovations. “Trinity Guardion is the world’s only manufacturer of launderable bed covers specifically engineered to eliminate bacteria, spores and viruses from a hospital bed mattress. I’m excited to present this patented technology with over 6 years of research behind it to this esteemed group of innovators,” states Bruce Rippe, Trinity Guardion’s Chief Operating Officer.

Healthovate! Summits give healthcare leaders an opportunity to share their expertise and engage in conversations with other leaders from other industries. Trinity Guardion will also be presenting at similar events in Boston (July 31), Chicago (Oct 5), and Nashville (Oct 28). “Our mission at the CFI is to use innovation to solve complex problems. I can’t think of a more important challenge facing our society than how we keep people healthy, while reducing costs and improving overall well-being,” said Shawn Nason, Chief Innovation Officer at Xavier University. “By bringing together a diverse community of people, all committed to health, I am confident we can find meaningful solutions and innovative technologies and systems that will transform the healthcare industry—not to mention better ways to educate and prepare students to work in and lead healthcare in the future.”

Over 40 area start-up hospitals, universities, national organizations, healthcare professionals, and Xavier alumni will learn how this innovative mattress cover acts as a barrier to prevent bacteria and fluids, which can be harbored in a hospital mattress as a result of ineffective cleaning, from coming in contact with a patient. Due to its abilities in preventing viruses such as Ebola and other bacteria from penetrating through the cover, hospitals have begun to implement the covers in their infection control wards. Last year, the innovative technology of the Trinity Bed Protection System was recognized when the honorable mention for the 2014 NALTH Goldberg Innovation Award was awarded to St. Vincent Seton Specialty Hospital, Indianapolis for their use of the mattress cover in their facility.

Tested in two Midwestern hospitals, the Trinity Bed Protection System does not impede bed operation or any clinical aspects of the underlying mattress. In fact, it helps reduce terminal clean time, while improving asset life of the bed.

The Trinity Bed Protection System from Trinity Guardion makes bed surfaces cleaner for every person every time.

About Trinity Guardion: Trinity Guardion is the result of an international collaboration of scientists, doctors and academic professionals in the healthcare industry, united in the concern that hospital beds are not clean. This concern was corroborated by peer reviewed research that is available upon request. The product line includes mattress covers for most brands of hospital beds, therapy tables and pillow cases.