C difficile: Guidelines to Diagnose, Treat, and Prevent
C difficile: Guidelines to Diagnose, Treat, and Prevent
C difficile recurs very frequently. If you've had an episode of C difficile, the likelihood of recurrence is approximately 20%-25%. After 2 episodes it goes up to 40%, and after 3 episodes it goes up to > 60% likelihood of recurrence. The recommendation for recurrence is to treat with the same drug that was used initially. So, if vancomycin or metronidazole was used initially, the patient should be re-treated with the same course. If they relapse a second time or if the infection is severe, then give vancomycin followed by vancomycin pulse dosing. Vancomycin 125 mg 4 times daily is given for 10 days, followed by 10 additional vancomycin doses of 125 mg. That is the pulse dose. If they have a third recurrence, they should be treated the same way. If they have recurrence more than 3 times, they should be considered for fecal microbiota transplantation. This has just been released as an opinion by the US Food and Drug Administration (FDA) in a public workshop that was held on May 2.
The FDA has come out officially and said that if you are doing fecal microbiota transplantation, it requires an investigational new drug (IND) application. This is something that you have to apply for by petitioning the FDA. They say that they will make this a rapid petition process, but again, it puts the hamstrings on a lot of us in clinical medicine who are actually trying to emergently engage in rectifying C difficile that may be quite toxic. So be aware of this.
How about microflora adjuncts? The probiotic role. There are very limited data on probiotic benefit. In fact, the probiotic benefit seemingly came from 1 trial with Saccharomyces boulardii, but there was a lot of stratification bias and it did not meet the rules of evidence to be included as a recommendation in the present guidelines. In fact, the guidelines state that other data, which were from studies on Lactobacillus, showed a decrease in antibiotic-related diarrhea but not C difficile, and there was no role for these agents as an adjunct for accelerated clearance or for prophylactic benefit as it relates to recurrent C difficile. That may be a new shocker for some of you.
Many people have been using Florastor® probiotics. If you are using these agents, please don't use them in hospitalized patients, particularly if they have central lines or are immunocompromised. There are cases of disseminated fungemia related to this. I think you need to be very careful if you are going to choose to use probiotics at all. There are some data about intravenous immunoglobulins that have been tried. There are no data to support their use, and the current recommendation came down fairly strongly along that line.
Recurrence and Other Treatments
C difficile recurs very frequently. If you've had an episode of C difficile, the likelihood of recurrence is approximately 20%-25%. After 2 episodes it goes up to 40%, and after 3 episodes it goes up to > 60% likelihood of recurrence. The recommendation for recurrence is to treat with the same drug that was used initially. So, if vancomycin or metronidazole was used initially, the patient should be re-treated with the same course. If they relapse a second time or if the infection is severe, then give vancomycin followed by vancomycin pulse dosing. Vancomycin 125 mg 4 times daily is given for 10 days, followed by 10 additional vancomycin doses of 125 mg. That is the pulse dose. If they have a third recurrence, they should be treated the same way. If they have recurrence more than 3 times, they should be considered for fecal microbiota transplantation. This has just been released as an opinion by the US Food and Drug Administration (FDA) in a public workshop that was held on May 2.
The FDA has come out officially and said that if you are doing fecal microbiota transplantation, it requires an investigational new drug (IND) application. This is something that you have to apply for by petitioning the FDA. They say that they will make this a rapid petition process, but again, it puts the hamstrings on a lot of us in clinical medicine who are actually trying to emergently engage in rectifying C difficile that may be quite toxic. So be aware of this.
How about microflora adjuncts? The probiotic role. There are very limited data on probiotic benefit. In fact, the probiotic benefit seemingly came from 1 trial with Saccharomyces boulardii, but there was a lot of stratification bias and it did not meet the rules of evidence to be included as a recommendation in the present guidelines. In fact, the guidelines state that other data, which were from studies on Lactobacillus, showed a decrease in antibiotic-related diarrhea but not C difficile, and there was no role for these agents as an adjunct for accelerated clearance or for prophylactic benefit as it relates to recurrent C difficile. That may be a new shocker for some of you.
Many people have been using Florastor® probiotics. If you are using these agents, please don't use them in hospitalized patients, particularly if they have central lines or are immunocompromised. There are cases of disseminated fungemia related to this. I think you need to be very careful if you are going to choose to use probiotics at all. There are some data about intravenous immunoglobulins that have been tried. There are no data to support their use, and the current recommendation came down fairly strongly along that line.
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