Background New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridiumdiffi cile infection. Methods Objective: To assess the ability of monoclonal antibodies directed against two toxins of C.diffi cile to prevent recurrence of disease. Design: Randomized, double-blind, placebo-controlled study Setting: 30 medical centers in the United States and Canada Subjects: 200 subjects with diarrhea and a positive stool toxin assay for C.difficile being treating with metronidazole or vancomycin Intervention: Antibodies administered together as a single infusion, each at a dose of 10 mg per kilogram of body weight Outcomes: 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. diffi cile infection was lower among patients treated with monoclonal antibodies (7% vs. 25%; 95% confi dence interval, 7 to 29; P <0.001). Th e absolute risk reduction (ARR) was 16%, yielded a number needed to treat (NNT) of 5.5. Th e recurrence rates among patients with the epidemic BI/NAP1/027 strain were 8% for the antibody group and 32% for the placebo group (P = 0.06); among patients with more than one previous episode of C. diffi cile infection, recurrence rates were 7% and 38%, respectively (P = 0.006). Th e mean duration of the initial hospitalization for inpatients did not diff er signifi cantly 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 (P = 0.09). Conclusions Th e addition of monoclonal antibodies against C. diffi cile toxins to antibiotic agents signifi cantly reduced the recurrence of C. diffi cile infection. (ClinicalTrials.gov number, NCT00350298 [ClinicalTrials.gov] .)
CITATION STYLE
Adalja, A. A., & Kellum, J. A. (2010). Clostridium difficile: moving beyond antimicrobial therapy. Critical Care, 14(5), 320. https://doi.org/10.1186/cc9249
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