The researchers conducted a double-blind, randomized, placebo-controlled trial involving 2,655 adults in 30 countries around the world. The study participants were suffering from primary or recurrent C. diff infections and were receiving standard-of-care antibiotics — metronidazole, vancomycin or fidaxomicin.
Investigators randomly assigned the participants to receive infusions of the following human monocalonal antibodies:
• A single dose of actoxumab
• A single dose of bezlotoxumab
• A single dose of bezlotoxumab plus actotoxumab
• A placebo (saline)
After the patients were cured of the initial C. diff infection, researchers followed up with the patients for 12 weeks.
The study shows the following percentage of patients from each group developed another C. diff infection:
• Placebo group: 27 percent
• Actoxumab group: 26 percent
• Bezlotoxumab group: 17 percent
• Bezlotoxumab/actotoxumab group: 15 percent
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