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Posts Tagged ‘C diff’

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June 19th, 2013

FDA, IND, FMT: Nine Letters, Some Common Sense, and a Real Video Link

Good news here — the FDA has reconsidered their requirement for an IND for fecal microbiota transplantation (FMT) for C diff: Some health care providers have stated that applying IND requirements will make FMT unavailable and have suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with […]


May 31st, 2013

Fecal Microbiota Transplantation — Try This At Home?

As noted before, the FDA says that an investigational new drug (IND) application is required for therapeutic use of fecal microbiota transplantation. The practical effect of this decision, at least at our institution, is to stop providing this service — it’s on hold pending those “internal discussions” planned by the FDA on the regulatory issues surrounding the […]


May 12th, 2013

FDA: Fecal Transplants Need Investigational New Drug Application

Gastroenterologists, ID doctors, C diff-sufferers, and microbiome-obsessed humanoids everywhere were treated to this surprising news recently — a decision by the FDA about fecal microbiota transplantation (FMT). From an email sent by the IDSA: Because fecal microbiota transplantation (FMT) is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for […]


January 17th, 2013

Why the Results of the C Diff Study (You Know Which One) Were No Surprise

In cased you missed it, fecal transplant — use of poop from a healthy donor, which is then infused into the colon either from above (nasogastric tube) or below (colonoscope) — is unquestionably the most effective treatment for people who have multiple recurrences of C. difficile colitis (C diff). We know this because of a […]


June 6th, 2012

A Fun Internet Poll for ID Nerds

Over on Medscape, one of my ID heroes, John Bartlett, has a new series called, “The Medscape Awards in Infectious Diseases” and it looks like a winner. Here’s how it works: The Medscape Awards in Infectious Diseases is a new series that will honor the greatest achievements in the field of infectious diseases during 1980-2012. […]


May 7th, 2012

Difficulties and Differences on C difficile

Some things in our field — diseases, treatments, generalizations, cliches, fads — have really changed since back in the early 1990s, when I started in this business. Here are a few that quickly come to mind: “Double coverage” of pseudomonas with a beta lactam plus an aminoglycoside was de rigueur MRSA was an inpatient concern […]


March 31st, 2010

C diff Guidelines: Metronidazole Still Preferred?

IDSA and The Society for Healthcare Epidemiology of America (SHEA) have published Clinical Practice Guidelines for Clostridium difficile infection. Not surprisingly, it’s a comprehensive, extensively-referenced document that will be an invaluable resource, especially since the previous version is approximately 15 years old. But with the caveat that I’m not an expert in this area, these particular […]


November 17th, 2008

Promising C diff Rx, and Google as Surveillance Tool

A few items from recent ID/HIV news: Bad enough when it happens once, relapsing C diff is one of the modern plagues for which our bag of tricks sometimes comes up woefully short.  (Anything that tests stool transplants as a therapy is pretty desperate.)  Here was some bright news on the treatment front, however:  an […]


September 18th, 2008

C. diff: The cure for antibiotic abuse

Even with market doom-and-gloom dominating the news, there’s a good article in yesterday’s Wall Street Journal on Clostridium difficile (C. diff).  It gives an accurate summary (in lay language) of the problem, several pertinent clinical anecdotes, and quotations from national experts. But this part in particular caught my eye: She says that among other measures, the […]


HIV Information: Author Paul Sax, M.D.

Paul E. Sax, MD

Contributing Editor

NEJM Journal Watch
Infectious Diseases

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