Monoclonal antibodies for treatment of Clostridium difficile infections

January 01, 0001

Monoclonal antibodies for treatment of Clostridium difficile infections

New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection. These US We performed a randomized, double-blind, placebo-controlled study of two neutralizing, fully human monoclonal antibodies against C. difficile toxins A (CDA1) and B (CDB1). The antibodies were administered together as a single infusion, each at a dose of 10 mg per kilogram of body weight, in patients with symptomatic C. difficile infection who were receiving either metronidazole or vancomycin. The primary outcome was laboratory-documented recurrence of infection during the 84 days after the administration of monoclonal antibodies or placebo.

They found: "Among the 200 patients who were enrolled (101 in the antibody group and 99 in the placebo group), the rate of recurrence of C. difficile infection was lower among patients treated with monoclonal antibodies (7% vs. 25). The recurrence rates among patients with the epidemic BI-NAP1-027 strain were 8% for the antibody group and 32% for the placebo group. Among patients with more than one previous episode of C. difficile infection, recurrence rates were 7% and 38%, respectively. The mean duration of the initial hospitalization for inpatients did not differ significantly between the antibody and placebo groups (9.5 and 9.4 days, respectively). At least one serious adverse event was reported by 18 patients in the antibody group and by 28 patients in the placebo group (NS)."

The authors concluded: "The addition of monoclonal antibodies against C. difficile toxins to antibiotic agents significantly reduced the recurrence of C. difficile infection."

This approach sounds promising for treatment of severe cases of C difficile infection.

For the full abstract, click here.

N Engl J Med 362(3):197-205 21 January 2010
© 2010 to the Massachusetts Medical Society
Treatment with Monoclonal Antibodies against Clostridium difficile Toxins. Israel Lowy, Deborah C. Molrine, Brett A. Leav, et al. Correspondence to: Dr. Molrine:

Category: D. Digestive, Keywords: Clostridium difficile, monoclonal antibodies, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 02 Februry 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.