Treatment with monoclonal antibodies against Clostridium difficile toxins
Department of Pediatrics; MassBiologics
Medical Subject Headings
Adult; Aged; Aged, 80 and over; Antibodies; Antibodies, Monoclonal; Antitoxins; Bacterial Proteins; Bacterial Toxins; Clostridium Infections; *Clostridium difficile; Diarrhea; Double-Blind Method; Drug Therapy, Combination; Enterocolitis, Pseudomembranous; Enterotoxins; Female; Humans; Male; Metronidazole; Middle Aged; Recurrence; Vancomycin; Young Adult
Immunology and Infectious Disease | Pediatrics
BACKGROUND: New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection.
METHODS: 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.
RESULTS: 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%; 95% confidence interval, 7 to 29; P
CONCLUSIONS: The addition of monoclonal antibodies against C. difficile toxins to antibiotic agents significantly reduced the recurrence of C. difficile infection. (ClinicalTrials.gov number, NCT00350298.)
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Citation: N Engl J Med. 2010 Jan 21;362(3):197-205. Link to article on publisher's site
Lowy, Israel; Molrine, Deborah C.; Leav, Brett A.; Blair, Barbara M.; Baxter, Roger; Gerding, Dale N.; Nichol, Geoffrey; Thomas, William D.; Leney, Mark; Sloan, Susan; Hay, Catherine A.; and Ambrosino, Donna M., "Treatment with monoclonal antibodies against Clostridium difficile toxins" (2010). Immunology/Infectious Disease. 66.