Fall 2018 - Integrated Care

Updated C. Diff Guidelines Reflect New Treatment Options and Recommendations

The Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA) have updated guidelines for diagnosis and management of Clostridium difficile (C. diff), which has become the leading cause of diarrhea in hospital patients and one of the most common healthcare-associated infections that sickens nearly 500,000 Americans and is associated with 15,000 to 30,000 deaths annually. The last IDSA/SHEA guidelines for C. diff were issued in 2010. And, while many of the recommendations remain the same, the updated guidelines reflect new treatment options and recommendations for who should be tested and which diagnostic tests are most appropriate.

The previous guidelines recommended metronidazole as first-line therapy for initial cases of mild-to-moderate C. diff and vancomycin for more severe cases. But, the updated guidelines recommend either vancomycin or fidaxomicin as the drug of choice for all initial episodes based on high-quality evidence that both drugs are superior to metronidazole. They also recommend both drugs for a first and second recurrence of C. diff. But, for patients who have had several bouts and have failed all appropriate antibiotic treatments, the guidelines recommend fecal microbiota transplantation (FMT), a procedure that involves the transfer of stool from a healthy donor into the colon of an infected patient. FMT is still considered an investigational treatment by the U.S. Food and Drug Administration, but it has produced strong results in anecdotal reports and in randomized clinical trials. “An important aspect of susceptibility to C. difficile, if not the majority of susceptibility, is due to disruption of the microbiota by antibiotics,” said Clifford McDonald, MD, senior advisor with the Centers for Disease Control and Prevention. “These patients can have multiple recurrent C. diff, they’re failing over and over again, and that’s where FMT is now another tool in the toolbox.”

The new guidelines also recommend testing be limited to those patients with more than three episodes of new-onset diarrhea within 24 hours, specifically patients whose symptoms aren’t attributable to underlying conditions or use of laxatives. In addition, it is recommended molecular tests, which have become increasingly popular in recent years due to their high sensitivity and quick diagnosis, be used on their own only when hospitals have established criteria for patients who are most likely to be at risk for C. diff. When the criteria don’t exist, a two- to three-step process that includes a toxin immunoassay plus a molecular test and/or an antigen test are recommended.

References

Dall C. New C Diff Guidelines Incorporate Fecal Transplant. Center for Infectious Disease Research and Policy, Feb. 16, 2018. Accessed at www.cidrap.umn.edu/news-perspective/2018/02/new-c-diff-guidelines-incorporate-fecal-transplant.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.