ACG publishes guidelines for preferred treatment of C. difficile infection
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ACG developed guidelines for the preferred management of adults with Clostridioides difficile infection, published in the American Journal of Gastroenterology.
“These guidelines are timely — we referenced new literature up until the final revision — and very clinically oriented. [Infectious Disease Society of America and Society of Healthcare Epidemiologists of America] published their own guidelines a few years ago,” Colleen R. Kelly, MD, told Healio Gastroenterology. “We aligned our categories of severity with theirs — non-severe, severe and fulminant infection — and decided not to dive deeply into epidemiology and infection control practices, which they covered nicely. Instead, we aimed to develop an evidence-based, clinically useful guideline for the diagnosis, management, and prevention of C. difficile infection and chose to expand on areas of particular interest to gastroenterologists, including diagnostic issues around diarrhea and distinguishing C. difficile colonization from active infection, and the evaluation and management of CDI in the setting of inflammatory bowel disease.”
The ACG used the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) process to evaluate the guidelines.
Recommendations for prevention, diagnosis, treatment, prevention of recurrence and special populations with C. difficile follow.
Prevention
- Probiotics for the prevention of C. difficile infection (CDI) should not be used in patients being treated with antibiotics or for the prevention of CDI.
“We critically appraised the data and did not find the evidence supported their use and the expense to patients,” Kelly, from the division of gastroenterology, Warren Alpert Medical School of Brown University, said.
Diagnosis
- CDI testing algorithms should include a highly sensitive and a highly specific testing modality to distinguish colonization from active infection.
Treatment
- Oral vancomycin 125 mg four times daily for 10 days is recommended to treat an initial episode of non-severe CDI. Oral fidaxomicin 200 mg twice daily for 10 days is recommended for an initial episode of non-severe CDI.
- Oral metronidazole 500 mg three times daily for 10 days should be considered for treatment of an initial non-severe CDI in low-risk patients.
- Vancomycin 125 mg four times a day for 10 days or fidaxomicin 200 mg twice daily for 10 days is recommended as initial therapy for severe CDI.
- Medical therapy including an adequate volume resuscitation and treatment with 500 mg of oral vancomycin every 6 hours daily is recommended for patients with fulminant CDI. Also, combination therapy with parenteral metronidazole 500 mg every 8 hours may be considered.
- The addition of vancomycin enemas (500 mg every 6 hours) may be beneficial in patients with an ileus.
- Fecal microbiota transplantation may be considered for patients with severe and fulminant CDI refractory to antibiotic therapy. Especially when patients are poor surgical candidates.
- Tapering/pulsed dose vancomycin is suggested for patients experiencing a first recurrence after an initial course of fidaxomicin, vancomycin or metronidazole. Fidaxomicin is recommended for patients experiencing a first recurrence after an initial course of vancomycin or metronidazole.
Prevention of recurrence
“Prior guidelines supported FMT after a third recurrence. Given that FMT appears safe and is the most effective way to prevent recurrence of C difficile (colonoscopically administered FMT is over 90% effective), we recommended FMT be used early in the cycle of recurrence (after second recurrence or third episode),” she said.
- Patients experiencing their second or further recurrence of CDI should be treated with FMT to prevent other occurrences. FMT should be delivered through colonoscopy or capsules for treatment of rCDI. Delivery by enema is suggested if other methods are unavailable.
- Repeat FMT is suggested for patients experiencing a recurrence of CDI within 8 weeks of an initial FMT. Suppressive oral vancomycin may be used to prevent further recurrence is patients with rCDI who are not FMT candidates, who relapsed after FMT or require ongoing or frequent courses of antibiotics.
- In patients with a history of CDI at high risk for recurrence, oral vancomycin is suggested during subsequent systemic antibiotic use to prevent additional recurrences.
- Zimplava (bezlotoxumab, Merck Connect) is suggested for prevention of CDI recurrence in patients who are at high risk for recurrence.
- Discontinuation of antisecretory therapy is recommended in patients with CDI, as long as there was appropriate indication for their use.
“Other ‘new’ recommendations include discussion around using vancomycin prophylactically during subsequent antibiotic use or to suppress C. difficile in patients with a history of CDI who are at high risk for recurrence,” Kelly said. “And we recommended limiting use of the monoclonal antibody bezlotoxumab to patients who were the most likely to benefit, including those aged 65 years or older with at least one of the following additional risk factors: experiencing their second episode of CDI within the past 6 months, immunocompromised, or severe CDI.”
Perspective
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Brian B. Baggott, MD, FACG
The ACG Clinical Guidelines for Clostridioides difficile infection are an essential resource for all primary care, gastrointestinal, infectious disease and surgeons caring for the C. difficile patient.
This article builds on the ACG 2013 guidelines and the Infectious Diseases Society of America (IDSA) and the Society of Healthcare Epidemiology of America (SHEA) publication in 2018.
The current article presents recommendations for the care of these patients using the GRADE system. Each recommendation is followed by an extensive summary of the current literature. Table 2 is a comprehensive summary of the authors’ recommendations. They specifically address prevention, diagnosis, treatment, prevention of recurrence and care of special populations: IBD, pregnancy/lactation, and the immunocompromised.
Regarding diagnosis, the authors present a succinct algorithm (Table 4 and Figure 1) using a two-tiered approach. The first line of testing should be either a highly sensitive NAAT (PCR) or GDH test, followed by the very specific toxin EIA. The authors discuss the challenges of the colonized but asymptomatic patient. They stress the importance of searching for other causes of diarrhea in the patient who is not responding to standard treatment, has a long history of chronic diarrhea, and symptoms more consistent with IBS.
Treatment is broken down into non-severe, severe (white blood cell count > 15,000 per mL of blood; creatinine> 1.5 mg/dL), fulminant (severe criteria plus hypotension, shock, ileus, or megacolon). Medical therapy for each group is evidence based. The role for FMT is discussed for each group. Exciting data are reported for sequential FMT in the fulminant colitis group directed by the presence of pseudomembranous colitis at the time of colonoscopy. These strategies have significantly decreased the need for colectomy.
Throughout the paper, the authors stress the importance of careful clinical observation and assessment of this population of patients. They stress avoiding treating only to test results and the importance of incorporating the clinical status and clinical course to determine the optimal strategy.
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