A recent update (Oct. 2020) of the guidelines for Clostridioides difficile infections (CDI) might allow clinicians to accurately predict viral severity in kidney disease patients.
In 2017, the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) revised their C. diff infection severity classification criteria to include an absolute serum creatinine (SCr) value above the threshold of at least 1.5 mg/dL as opposed to a relative increase from baseline of at least 1.5 times the premorbid level.
A team, led by Travis J. Carlson, Department of Clinical Sciences, High Point University Fred Wilson School of Pharmacy, sought to best define kidney injuriesas a CDI disease severity marker to make it easier to assess severe outcomes linked to CDI.
In the multicenter, cohort study, the investigators assessed adult hospitalized patients with a C. diff infection for the presence of an acute kidney injury (AKI), chronic kidney disease (CKD), and CDI severity using the 2010 and 2017 IDSA/SHEACDI guidelines.
The investigators sought primary outcomes of all-cause inpatient mortality.
In the final analysis, the investigators examined 770 C. diff infection episodes from a total of 705 patients aged 65±17 years (female, 54%; CKD, 36.5%; AKI, 29.6%).
In addition, 82 episodes (10.6%) showed discordant severity classification results because of the inclusion of more patients with preexisting chronic kidney disease in the severe disease category using an absolute SCr threshold criterion.
The absolute SCr criterion better correlated with all-cause mortality (OR, 4.04; 95% CI, 1.76-9.28; P = 0.001) than the relative increase in SCr (OR, 1.34; 95% CI, 0.62-2.89; P = 0.46).
The investigators found this corresponded with an increased likelihood of the 2017 CDI severity classification criteria to predict mortality (OR, 5.33; 95% CI, 1.81-15.72; P = 0.002) compared to the 2010 criteria ( OR, 2.71; 95% CI, 1.16-6.32; P = 0.02).
“Our findings support the 2017 IDSA/SHEA CDI severity classification criteria of a single pre-treatment SCr in future CDI guideline updates,” the authors wrote.
New data shows positive trends regarding C. diff infections and hospitalization within the last 10 years.
A team, led by Alice Y. Guh, MPH, identified cases of C. diff infections in stool specimens positive for C. diff in an individual at least 1-year-old with no positive test in the previous 8 weeks in 10 US sites.
Overall, they identified 15,461 cases in 2011—10,177 healthcare-associated cases and 5284 community-associated cases. In 2017, they identified 15,512 cases—7973 healthcare-associated cases and 7539 community-associated cases.
The estimated national burden of infections was 476,400 (95% CI, 419,900-532,900) in 2011 and 462,100 cases (95% CI, 428,600-495,600) in 2017.
After accounting for NAAT use, the adjusted estimate of the total burden of C. diff infection decreased by 24% from 2011 through 2017 (95% CI, 6-36).
The South Carolina Hospital Association (SCHA) has awarded Williamsburg Regional Hospital for their tremendous efforts eliminating medical errors as part of their Zero Harm program.
Williamsburg Regional Hospital won awards for CLABSI ICU 78 months,
CLABSI Hospital-wide 78 months,
Hospital onset C. diff. 24 months,
SSI Colon Surgery 30 months,
Hospital onset MRSA 66 months,
a testament to the dedication of their clinical staff and the facility’s commitment to the highest quality of care, even in the face of the extraordinary challenges posed by the COVID-19 pandemic.
SCHA’s Zero Harm Awards were started in 2014 to celebrate hospitals that have had extended harm-free stretches in major surgical areas like knee replacements, hip replacements, colon surgery, and abdominal hysterectomy or gone months without a Central Line-Associated Blood Stream Infection (CLABSI). These awards are indicative of a culture committed to patient safety and providing highly reliable care. All of the hospital data used for these awards is also independently verified by the South Carolina Department of Health and Environmental Control.
South Carolina hospitals are at the forefront of a larger movement towards high reliability and a Zero Harm mindset. Thanks to collaborations with BlueCross BlueShield of South Carolina and The Joint Commission Center for Transforming Health, South Carolina hospitals have been united in statewide efforts to create a culture of high reliability and reduce harm in our facilities by implementing robust, evidence-based practices that are making a positive impact on patients and the safety and quality of care.
According to Thornton Kirby, President, and CEO of SCHA, the Zero Harm Awards are also part of the Association’s efforts to guide and support the state’s hospitals in creating true “Zero Harm” cultures by recognizing the efforts of the amazing clinicians in South Carolina’s hospital and health systems who work every day to provide high-quality care.
“Zero Harm is about taking the principles of high reliability and applying them to how we deliver healthcare in South Carolina,” said Kirby. “The fact that the state’s hospitals increased the number of Zero Harm Awards in the midst of a global pandemic is a testament to their commitment to improving care delivery.”
For a full list of 2020 Zero Harm winners and to learn more about the program, please visit the SCHA Certified Zero Harm webpage.
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Findings from a study by researchers from the University of Iowa highlights the potential role of the home environment in Clostridioides difficile transmission.
Using data from a commercial insurance claims database, the researchers found that the incidence of C difficile infection (CDI) among individuals living with a family member who had CDI was more than 12 times greater than the incidence in those without prior family exposure. The incidence rate was even higher in certain groups less likely to have other risk-increasing exposures.
While the level of absolute CDI risk attributable to the household transmission was extremely low, the authors of the study say the findings may have practical implications for preventing the spread of CDI in households.
CDI can be spread in the community
C. difficile infection (CDI) is a common, typically hospital-acquired infection that is mainly associated with antibiotic use and healthcare settings. While antibiotics create the conditions that allow for C difficile to flourish in the gut and cause infection, spores shed by infected patients (through fecal matter) and can be spread by healthcare workers and are frequently found on *bed rails, in the patient bathrooms, and other parts of the hospital environment.
(*High touch areas can be easily contaminated with Clostridioides difficile (C. difficile, C. diff.) spores) cdf note.
Those spores are often difficult to eliminate because they are resistant to many cleaning agents.
In 2017, according to the most recent data from the Centers for Disease Control and Prevention, there were an estimated 223,900 CDI cases in hospitalized patients.
But not all CDI cases start in hospitals. Some studies have found that CDI can be transmitted outside of healthcare settings, with persistent contamination of the household environment occurring in patients with documented infection. Others have found household pets colonized with the bacterium.
To better understand the potential role of household C difficile transmission, the University of Iowa researchers used a large population-based, commercial insurance claims data set to examine whether family members of CDI patients had a greater risk of acquiring the infection. Limiting the analysis to households with two or more family member enrolled in the same insurance plan for an entire month, they grouped individuals into four categories based on CDI status and family exposure to CDI: (1) CDI and prior family exposure, (2) no CDI and prior family exposure, (3) CDI and no family exposure, and (4) no CDI and no family exposure.
The primary outcome of the case-control study was the incidence of CDI in a given monthly enrollment stratum. Aside from exposure to CDI diagnosed in a family member, other CDI exposure risks were considered, including prior hospitalization, age, and antibiotic use. The researchers also conducted a separate analysis for CDI diagnosed in hospital or outpatient settings.
Higher risk from family exposure
Analysis of data covering 2001 through 2017 found that 224,818 CDI cases, representing 194,424 enrollees, occurred in families with at least two enrollees. Of these, 1,074 CDI cases (0.48%) occurred following a diagnosis in a separate family member, representing possible transmission. In general, the index cases of CDI tended to occur in older enrollees (ages 45 to 64 years), while the CDI cases that represented potential transmission events occurred in children.
A comparison of the incidence rate ratio (IRR) between individuals with and without family exposure showed that prior family exposure was significantly associated with an increased incidence of CDI (IRR, 12.47; 95% confidence interval [CI], 8.86 to 16.97) even after controlling for other risk factors. This was the second-highest IRR behind hospital exposure (IRR, 16.18; 95% CI, 15.31 to 17.10).
Increased CDI incidence was also associated with age (IRR, 9.90; 95% CI, 8.93 to 10.98 for people over age 65 compared with those aged 0 to 17) and antibiotic use (IRR, 7.78; 95% CI, 7.33 to 8.25 for people on high-CDI-risk antibiotics compared with no antibiotics).
When the researchers looked at subgroups of CDI cases less likely to be attributed to hospital exposure, they found that the IRR associated with family exposure was even higher—16.00 (95% CI, 11.72 to 21.22) for community-onset CDI and 21.74 (95% CI, 15.12 to 30.01) for community-onset CDI without prior hospitalization.
“For individuals with family exposure, the risk for being diagnosed with CDI remained consistent after controlling for CDI risk factors and different model specifications,” the authors wrote. “Together, these results suggest that individuals with family exposure may be at greater risk for acquiring CDI than those without exposure and highlight the importance of the shared environment in the transmission and acquisition of C difficile.”
The authors note that because they were not able to conduct whole-genome sequencing, they cannot confirm whether CDI cases within families represent identical strains. They also said the study is limited by the reliance on insurance claims data, which do not provide all the details necessary to determine attributable risk.
Despite the low absolute risk of acquiring CDI from a family member, the authors suggested that cleaning shared bathrooms with effective cleaning agents could be a practical way to minimize transmission risk.
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For example, new data published in The New England Journal of Medicine underscore the shortcomings of advances in testing technology, suggested Sahil Khanna, MBBS, an associate professor of medicine at Mayo Clinic College of Medicine and Science in Rochester, Minn. (2020;382:1320-1330).
At first glance, the study, which used data from 10 sites around the United States to derive a national estimate of the incidence of C. difficile infection (CDI), reported a relatively unchanged rate of the disease over a six-year period: 476,400 cases in 2011 and 462,100 cases in 2017. However, after adjusting for the increasing use of nucleic acid amplification testing (NAAT), the researchers concluded that the incidence of CDI had actually decreased by 24% during the study period, including a 36% drop in healthcare-acquired CDI cases.
The study highlights a problem with NAAT, according to Khanna. “NAAT is approximately 95% sensitive in detecting the C. difficile gene, but it cannot determine if the gene is active and toxin-producing, so it has the potential for overdiagnosis and for producing clinical false positives,” he explained. “Because of this, it’s important that we interpret NAAT results in the context of patient symptoms.”
Clinicians must be selective when deciding which patients should be tested, he said, adding that it only should be used in patients who have acute diarrhea with no obvious alternative explanation and risk factors for CDI such as older age, longer hospitalization, immunosuppression, use of antibiotics, gastric acid-suppressing agents, gastrointestinal surgery, manipulation of the gastrointestinal tract and tube feeding.
“Patients not experiencing an active infection can be colonized with C. difficile, in which case there is a risk of clinical false positives and unnecessary treatment,” Khanna emphasized.
An alternative testing approach recommended by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) is the use of a multistep algorithm including glutamate dehydrogenase (GDH) to identify pathogenic bacteria and enzyme immunoassay (EIA) to detect C. difficile toxin (Clin Infect Dis 2018;66:e1-e48). NAAT should be reserved for instances in which results from GDH and EIA are inconclusive, the guidelines recommend.
Laboratories are increasingly adopting a two-step protocol of GDH and EIA, but “NAAT remains the most commonly used test method,” Khanna said.
The treatment landscape for CDI also has changed over the past few years, noted Kim Ly, PharmD, a clinical pharmacy specialist in critical care and infectious diseases at Sunrise Hospital and Medical Center, in Las Vegas. Bezlotoxumab (Zinplava, Merck), a monoclonal antibody, is approved for the combination treatment of toxin B–producing CDI, along with an established antibiotic. Additionally, metronidazole, while still approved for the treatment of CDI, is no longer recommended by IDSA/SHEA as a first-line agent for primary CDI in adults.
“For severe initial episodes of CDI, oral vancomycin and fidaxomicin [Dificid, Merck] are now the preferred agents, and metronidazole is only recommended for nonsevere initial episodes when patients are unable to be treated with oral vancomycin or fidaxomicin,” Ly explained.
For a first recurrence of CDI, the IDSA/SHEA guidelinesrecommend administering oral vancomycin as a tapered and pulsed regimen or fidaxomicin, rather than a standard 10-day course of vancomycin. For subsequent recurrences, clinicians can use the same regimen, with the addition of a standard course of oral vancomycin followed by rifaximin or fecal microbiota transplantation (FMT).
Metronidazole comes into play again in the management of fulminant CDI, Ly noted.“The IDSA/SHEA guidelines recommend treating this with oral or rectal vancomycin 500 mg four times daily along with intravenous metronidazole,” she explained.
Given that antibiotic-induced microbiota disruption “is far and away the number one precipitant for getting recurrent CDI,” selecting the CDI treatment with the least impact on the microbiota is important, said former IDSA president Cynthia Sears, MD, a professor in the Department of Medicine, Division of Infectious Diseases, at the Johns Hopkins University School of Medicine, in Baltimore.
“Vancomycin is the most commonly used therapy for CDI and its recurrences, but it decreases intestinal diversity and so impedes the recovery of the normal microbiota after CDI, setting the stage for CDI recurrence,” Sears said. “We have learned that vancomycin hits the colon with full force when taken orally because it is not absorbed, and it has off-target effects on lots of anaerobic bacteria that are essential to intestinal resistance of CDI.”
Fidaxomicin has less of an effect on the microbiota and has been shown to sometimes decrease the risk for CDI recurrence compared with vancomycin (N Engl J Med 2011;364:422-431), but it can be expensive, she said.
Fecal Microbiota Transplantation
FMT is a less expensive, highly effective treatment that has received increasingly widespread attention, specifically for the management of recurrent CDI. Despite the enthusiasm surrounding the treatment, Sears expressed significant reservations about employing it. “While there’s no question that FMT benefits patients with recurrent CDI, I feel we don’t yet have a quality-controlled product that we know is safe as well as being effective,” she said.
Sears pointed to two recent FDA safety alerts that warned of the harm that FMT can cause. The first, from 2019, reported that stool from a single donor had not been thoroughly screened before FMT and contained extended-spectrum beta-lactamase-producing Escherichia coli. The specimen had been used in separate FMTs for two immunocompromised patients, leading to infection with the pathogen and death in one case (https://bit.ly/2Teockd).
In another FDA safety alert from earlier this year, the organization said a stool bank specimen that had undergone comprehensive screening nevertheless contained enteropathogenic E. coli and Shiga toxin-producing E. coli. Transfer of the stool for the treatment of recurrent CDI resulted in one nonfatal infection and one death (https://bit.ly/31q5LO0).
“Stool banks try very hard to be sure their specimens are free of disease-causing microbes, but if you have very low-level colonization, molecular diagnostics can miss this,” Sears said. More recently, she noted, the FDA has also raised concerns about the possibility of transferring SARS-CoV-2 through FMT, given that the virus can be present in the stool of infected individuals (https://bit.ly/37sMPBX).
What would a safer and equally effective microbiota-based treatment look like?
According to Sears, although microbial diversity seems to be protective against recurrent CDI, there are suggestions that the administration of specific strains may be able to treat CDI and can be produced under the same strict quality control manufacturing processes as other FDA-approved drugs.
One study published in 2015 using human and mouse samples found that colonization with Clostridium scindens, a strain of Firmicutes, increased resistance to CDI (Nature 2015;517:205-208).
Many microbiota-based therapeutics are in the research pipeline as well.
“I am optimistic that we will see something emerge that’s safer and still as effective as FMT for patients,” Dr. Sears said, “whether it’s an orally or rectally administered product.”
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Clostridioides difficile is a dangerous human pathogen because it can grow to high numbers in the intestine, cause colitis with its potent toxins, and persist as spores. C. difficile infection (CDI) is the primary hospital-acquired infection in North America and Europe, and it now is a global disease. Even with newer laboratory tests, there still is confusion on accurately diagnosing this disease. Three guidelines from three different healthcare-affiliated societies have recently been published. Consensus consolidated recommendations from these guidelines should be recognized by healthcare professionals, who need to understand why this disease continues to be difficult to diagnose and need a clear understanding of the advantages and limitations of current tests. Hopefully, these combined efforts will lead to an improvement in the recognition of this pathogen and a reduction in the suffering and economic loss caused by CDI.
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