Investigators at IDWeek 2019 presented the final, 24-month analysis of data from a phase 2 open-label trial of RBX2660 for the prevention of CDI recurrence. Patients with multi-recurrent CDI were enrolled in the multicenter study and received > 2 doses of RBX2660 delivered via enema 7 days apart.
The research team defined efficacy as absence of CDI recurrence through 56 days after the last dose, and durability as continued absence of CDI episodes beyond 8 weeks. Results were compared with the 8-week recurrence-free rates for a historical control cohort that received standard-of-care antibiotic therapy.
Participant stool samples were collected prior to and for up to 720 days after treatment, and safety and durability assessments were performed at 3, 6 ,12, and 24 months. Investigators assessed microbiome changes via shallow shotgun sequencing.
By:Saskia v. Popescu Saskia v. Popescu, MPH, MA, CIC, is a hospital epidemiologist and infection preventionist with Phoenix Children’s Hospital. During her work as an infection preventionist she performed surveillance for infectious diseases, preparedness, and Ebola-response practices. She is currently a PhD candidate in Biodefense at George Mason University where her research focuses on the role of infection prevention in facilitating global health security efforts. She is certified in Infection Control.
Clostridium difficile (C diff) infections are pretty much a nightmare for infection preventionists. They cause horrible illness in patients and the spore is environmentally hardy, which makes disinfection efforts extremely challenging. The US Centers for Disease Control and Prevention (CDC) estimates that, in the United States, half a million cases of C diff occur every year, and roughly 15,000 people die due to the infection. As a result of the severity of these infections and the challenges for infection control, it’s not surprising that surveillance and reporting is required not only by many state laws, but also reimbursement regulations through the Centers for Medicare and Medicaid Services (CMS). All of these factors make C diff prevention a major focus for hospitals.
Since the C diff spores are so environmental hardy, cleaning and disinfecting is particularly challenging. Bleach products are required to combat the spread of the spores on surfaces and fomites while soap and water is required for hand hygiene instead of alcohol-based hand sanitizer. These cleaning requirements pose problems though; sometimes bleach can be corrosive on medical equipment if manufacturer guidelines aren’t followed. Moreover, C diff can easily spread if patients aren’t isolated appropriately, if the room isn’t cleaned effectively, if hygiene failures occur, etc. One of the tough aspects of infection control in the face of C diff is the role of the asymptomatic carrier (i.e. the patient who is not experiencing symptoms that would trigger testing and isolation precautions but has the capacity to shed the spores).
A new study in the American Journal of Infection Control sought to address this often undervalued vector for transmission and the true burden of C diff spores in rooms after they were cleaned post-discharge and did not house a C diff patient. Investigators used the Louis Stokes Cleveland Veterans Affairs Medical Center, a 215-bed acute care facility, to test whether cleaning with bleach products in non-C diff rooms would impact contamination.
Prior to their study, daily and discharge cleaning for C diff rooms utilized bleach wipes, while a quaternary ammonium disinfectant was used for non-C diff rooms. Investigators used Clorox Healthcare Fuzion Cleaner, which is a bleach spray that has less corrosive effects. Although cleaning efficacy had previously been measured with fluorescent markets, the team relied on cultures to identify both C diff spore and methicillin-resistant Staphylococcus aureus (MRSA) contamination for this study.
Non-C diff rooms were tested for 3 weeks before the switch to the bleach-spray disinfectant and then, after the swap, tested again after cleaning of the room but before admission of a new patient. Ultimately, the goal was to determine how many rooms had environmental contamination with C diff spores before and after the change in disinfectants.
There were 51 non-C diff rooms tested after the post-discharge cleaning and prior to the switch to the bleach spray, and 39 non-C diff rooms were cultured after switching to the bleach product. The results were pretty astounding and definitely make the case for using bleach-based products in all post-discharge rooms.
Prior to switching products, 24% (12/51) of the rooms had contamination of at least one site (room and/or bathroom) and 10% had MRSA contamination. When cleaning practices were switched to use the bleach spray, the rate of contamination severely dropped—2 of 39 rooms. This trend was statistically significant and also seen in the MRSA contamination.
In this case, the investigators found that by using the bleach-based spray for the post-discharge cleaning of a non-C diff patient’s room, they reduced the contaminationfrom 24% to 5%.
Although the study is limited to a single hospital, it encourages further investigation into general C diff contamination throughout hospitals and whether bleach-based cleaning should be performed upon all discharges, regardless of patient diagnosis with C diff infections.
As C diff continues to grow as a public health and health care concern, the role of environmental contamination will only become more critical. This study sheds light on a new cleaning strategy for hospital-wide disinfecting efforts to reduce microbial burden and C diff contamination.
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“This is a review/commentary article that provides a high-level overview of the literature dealing with C. diff colonization and the microbiome changes associated with C. diff colonization,” author Silvia Munoz-Price, MD, PhD, from the Medical College of Wisconsin in Milwaukee told our sister publication MD Magazine.
After reviewing the literature, authors of the study postulated that when it comes to the potential for C. diff colonization, exposure to and transmissions of the virus occurs outside of hospitals. In fact, it seemed like most of the patients became symptomatic during their hospital stay, rather than acquiring the virus while hospitalized.
For example, the investigators cited one study from Canada that had been conducted from 2006 to 2007 where more than 4000 patients were screened for C. diff colonization upon hospitalization, during their stay (on a weekly basis) and at discharge. They found that 4% of the patients were colonized upon hospitalization and 3% acquired C. diff during their stay in the hospital.
The authors also found evidence indicating that community-acquired C. diff appears to be on the rise. The authors discuss a decade-long study which took place in Minnesota where community-acquired C. diff infection rates rose from 2.8 to 14.9 per 100,000-person-years within the 10-year span. The patients in that study more likely to acquire C. diff were younger, female, and healthier than patients with hospitalization acquired C. diff. The reviewers also said that rates of community-acquired C. diff have also been rising in Finland, Australia, and England, according to published studies.
Most of the common risk factors for community-acquired C. diff infections still applied, the researchers found, including antibiotic exposure, household contact, and animals. A 2013 study showed that two-thirds of community-acquired C. difficile patients were exposed to antibiotics in the preceding 12 weeks of their infection, and about one-third had been exposed to proton pump inhibitors.
While studies examining transmissibility within households are difficult to come by, the study authors found one review from Quebec. The review consisted of 2222 cases of C. diff diagnosed between 1998 and 2009, and investigators found that 8 cases were designated to be transmitted by household contacts. However, the researchers noted, confirmation using strain typing was not performed in that study.
Looking at farm livestock, a 2013 Dutch study showed that individuals with daily contact with pigs showed rates of C. diff positivity of 25%; in those with weekly contact, it was 14%. In the same study, C. diff was found in the manure from all the farms in 10% to 80% of the samples per farm. The reviewers also said that C. diff has been found in the stool of farm chickens, calves, and retail ground meat. Dogs and cats are also known to culture positive for C. diff, and the researchers wrote that the bacteria can also be present in vegetables and water (tap water, swimming pools, as well as rivers, lakes, and seas). They hypothesized that the presence of C. diff in vegetables may come from the use of organic fertilizer.
“We envision that in the future we should be able to take advantage of our increasing knowledge about microbiome changes so that we will be able to: identify patients at risk for de novoC. difficile colonization during their hospitalization and manipulate our patients’ microbiome to prevent or reverse C. difficile colonization,” Dr. Munoz-Price said.
“Different from what we do now, the latter would be accomplished not by withholding or changing antibiotics but by correcting the deficient flora of a patient in an individualized fashion. This new approach would revolutionize the field of Infection Control and Antibiotic Stewardship,” she concluded.
Health care facilities everywhere have been ramping up their disinfection practices in order to prevent the spread of infectious diseases. However, when it comes to hospital mattresses, one of the biggest vectors for spreading deadly bugs, efforts are still falling short.
With health care workers using chemicals that are intended for dry surfaces, the mattresses are harboring pathogens such as Clostridium difficile (C. diff), and, as Edmond A. Hooker, MD, DrPH, professor in the Department of Health Administration at Xavier University, pointed out at the 5th Annual International C. diff Awareness & Health Expo, regulatory agencies seem to have “turned a blind eye” to the issue.
The US Food and Drug Administration (FDA) recently released a notice on how to keep hospital mattress covers safe.
In this notice, the FDA notes safety concerns regarding hospital mattress covers, particularly that over time they can “wear out and allow blood and body fluids to penetrate and get trapped inside mattresses.” They added, “If blood or body fluids from one patient penetrate and get absorbed in a mattress, the fluids can leak out the next time the mattress is used.” If that happens, the next patient runs the risk of coming into contact with these fluids, and thus, becoming infected with pathogens from the bed’s previous occupants.
The FDA reports that this is not the first time they acknowledged these concerns; they released a safety communication in 2013 to make health care workers aware of the issue. However, the problem of contaminated hospital mattresses persists.
“There is no question there has been report after report after report of, ‘We had this outbreak. We killed all these people.’ There was just a report that came out on 18 people who were sick in a French hospital; they were on beds manufactured here in America, and 4 people were killed before they finally realized that it was the mattresses. They took all of the mattresses out of service and stopped the outbreak,” Dr. Hooker told Contagion® in an exclusive interview.
“There’s a reason that it’s an under reported problem; hospitals don’t want to say, ‘Hey, we just killed a bunch of people. We kill 29,000 people a year with C. difficile infections. Do you hear that? I mean, that’s like crashing a plane every day and we do nothing about it. We just act like it didn’t happen.”
In an effort to address the issue, the FDA has released recommendations based on Centers for Disease Control and Prevention (CDC) guidelines for environmental infection control in health care facilities; they include:
Develop an inspection plan for all hospital mattresses and mattress covers in the facility. Learn the time of life for all mattresses/mattress covers by checking the manufacturer’s guidelines; follow any other recommendations that the manufacturers list. If you have any additional questions, contact the mattress manufacturer.
Inspect each hospital mattress for visible signs of damage, which can include: cuts, tears, cracks, pinholes, snags, or stains. On a routine basis, remove mattress covers and check the inside. With the cover removed, check the mattress for wet spots, staining, or other signs of damage. Be sure to check all sides of the mattress as well as underneath. You will not be able to effectively inspect the mattress with the cover on.
Remove any mattresses that are damaged, appear worn, or are visibly stained and immediately replace any mattress covers that are damaged.
Maintain your mattresses and mattress covers by cleaning and disinfecting them “according to the manufacturer’s guidelines.” DO NOT stick needles into the hospital mattress through the cover, the FDA stresses.
“The FDA notice about mattress failures is an important first step. However, much more needs to be done. Most failures are not being reported to FDA, and the 700 reports that they have represents an industry-wide problem. Up to one-third of hospital mattresses currently in service in hospitals have failed. Also, the ones that have not failed are not being cleaned,”
Dr. Hooker stressed to Contagion® in a follow-up interview. “These mattresses quickly get fissures and microscopic cracks that allow bacteria to remain on the surface during terminal cleaning. The next patient is then exposed to those bacteria and gets a hospital-acquired infection. The CDC needs to mandate better cleaning practices nationwide, which they can do.
The CDC needs to also mandate inspection of every mattress after every patient. Damaged mattresses should be removed from service immediately.”
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Belinda Ostrowsky, MD, MPH, Health Systems Director of Epidemiology, Antimicrobial Stewardship & Infection Prevention, Montefiore Medical Center, and Associate Professor of Clinical Medicine, Division of Infectious Diseases, Department of Medicine, Albert Einstein College of Medicine, explains how to be more sensible when it comes to testing for Clostridium difficile.