Abstract
Background New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection. Methods Objective To assess the ability of monoclonal antibodies directed against two toxins of C.difficile 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. difficile infection was lower among patients treated with monoclonal antibodies (7% vs. 25%; 95% confidence interval, 7 to 29; P < 0.001). The absolute risk reduction (ARR) was 16%, yielded a number needed to treat (NNT) of 5.5. The 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. difficile infection, recurrence rates were 7% and 38%, respectively (P = 0.006). 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 (P = 0.09). 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 [ClinicalTrials.gov].)
Highlights
New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection
The addition of monoclonal antibodies against C. difficile toxins to antibiotic agents significantly reduced the recurrence of C. difficile infection. (ClinicalTrials.gov number, NCT00350298 [ClinicalTrials.gov] .)
Commentary Infection with Clostridium difficile places a significant burden on healthcare facilities
Summary
New therapies are needed to manage the increasing incidence, severity, and high rate of recurrence of Clostridium difficile infection. Methods Objective: To assess the ability of monoclonal antibodies directed against two toxins of C.difficile 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 laboratorydocumented recurrence of infection during the 84 days after the administration of monoclonal antibodies or placebo.
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