Lowy, IsraelMolrine, Deborah C.Leav, Brett A.Blair, Barbara M.Baxter, RogerGerding, Dale N.Nichol, GeoffreyThomas, William D.Leney, MarkSloan, SusanHay, Catherine A.Ambrosino, Donna M.2022-08-232022-08-232010-01-222012-05-01N Engl J Med. 2010 Jan 21;362(3):197-205. <a href="http://dx.doi.org/10.1056/NEJMoa0907635">Link to article on publisher's site</a>0028-4793 (Linking)10.1056/NEJMoa090763520089970https://hdl.handle.net/20.500.14038/43485BACKGROUND: 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.)en-USCopyright © 2010 Massachusetts Medical Society. PDF posted as allowed by the publisher’s Author Permissions policy at https://www.nejm.org/author-center/permissions.AdultAgedAged, 80 and overAntibodiesAntibodies, MonoclonalAntitoxinsBacterial ProteinsBacterial ToxinsClostridium Infections*Clostridium difficileDiarrheaDouble-Blind MethodDrug Therapy, CombinationEnterocolitis, PseudomembranousEnterotoxinsFemaleHumansMaleMetronidazoleMiddle AgedRecurrenceVancomycinYoung AdultImmunology and Infectious DiseasePediatricsJournal Articlehttps://escholarship.umassmed.edu/peds_immunology/662814397peds_immunology/66