Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Prevention of Recurrent Clostridium difficile
N Engl J Med; ePub 2017 Jan 26; Wilcox, et al
Among patients receiving antibiotic treatment for primary or recurrent Clostridium difficile (C. difficile) infection, those taking bezlotoxumab experienced a substantially lower rate of recurrent infection when compared to placebo, a recent study found. MODIFY I and MODIFY II were 2 double-blind, randomized, placebo-controlled, phase 3 trials that included 2,655 adults with primary or recurrent C. difficile infection receiving oral standard-of-care antibiotics plus either an infusion of bezlotoxumab, actoxumab plus bezlotoxumab, or placebo. Actoxumab alone was given in MODIFY I but discontinued. Researchers found:
- In both trials, the rate of recurrent C. difficile was significantly lower with bezlotoxumab alone than with placebo and was significantly lower with actoxumab plus bezlotoxumab than with placebo.
- Rates of initial clinical cure were 80% with bezlotoxumab alone, 73% with actoxumab plus bezlotoxumab, and 80% with placebo; rates of sustained cure were 64%, 58%, and 54%, respectively.
- The addition of actoxumab did not improve efficacy.
Wilcox MH, Gerding DN, Poxton IR, et al. Bezlotoxumab for prevention of recurrent Clostridium difficile infection. N Engl J Med. 2017; 376:305-317. doi:10.1056/NEJMoa1602615.
This Week's Must Reads
Must Reads in Infectious Diseases
Rapid Point of Care Test for Influenza, J Am Board Fam Med; 2019 Mar; Dale, et al
Invasive GBS Infections in Nonpregnant US Adults, JAMA Intern Med; ePub 2019 Feb 18; Francois Watkins, et al
Prescribed Opioids & Risk of CAP in Patients with HIV, JAMA Intern Med; 2019 Jan 7; Edelman, et al
Influenza Vaccination Safety During Hospitalization, Mayo Clin Proc; ePub 2019 Jan 8; Tartof, et al
Hospitalization Trends for Drug-Use Associated IE, Ann Intern Med; ePub 2018 Dec 4; Schranz, et al
Clostridium difficile has become a common cause of post-antibiotic diarrhea among both hospital inpatients and patients in the community. With current treatment regimens of metronidazole or oral vancomycin, up to 35% of patients develop recurrent C. difficile infection.1,2 Recurrences tend to be more severe, have a higher chance of re-occurrence, and have worse outcomes. Actoxumab and bezlotoxumab are monoclonal antibodies against C. difficile toxins A and B respectively. By binding and neutralizing the circulating antibody, the agent active against the B toxin, bezlotoxumab appears to decrease recurrences of C. difficile. This new method of treatment is promising, and along with other new methods including fecal transplant, will likely have find their optimal value in patients with recurrent C. difficile. —Neil Skolnik, MD