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Clostridium difficile infection (CDI) is a toxin-mediated illness. Antibiotic disruption of the normal intestinal flora is generally needed before such infection occurs, and antibiotic treatment of CDI is associated with recurrence; therefore, treatment strategies based on neutralization of toxin without antibiotics could be beneficial. One potential agent is tolevamer, a high-molecular-weight, soluble polymer of styrene-sulfonate that binds and neutralizes C. difficile toxins in vitro.
To examine this possibility, researchers (with industry support) conducted two phase III, multicenter, placebo-controlled trials. A total of 1118 adults with primary or recurrent CDI were randomized to receive 125 mg of oral vancomycin or 375 mg oral metronid…