title: Antibodies to Toxin B Are Protective Against Clostridium difficile Infection Recurrence.
abstract: Although newer studies have evaluated risk factors for recurrent Clostridium difficile infection (CDI), the vast majority did not measure important biomarkers such as endogenous anti-toxin A and anti-toxin B antibody levels.
  
  
  
  Data from the placebo group of a phase 2 trial testing monoclonal antibodies to C. difficile toxins A and B for preventing CDI recurrence (rCDI) were analyzed to assess risk factors associated with rCDI. Patients with symptomatic CDI taking metronidazole or vancomycin were enrolled. The primary outcome was rCDI within 84 days of treatment start. Univariate and multivariate logistic regression was used to examine associations between potential risk factors and rCDI. At baseline, demographic and clinical characteristics were recorded; endogenous antibody levels were assessed using 2 enzyme-linked immunosorbent assays.
  
  
  
  A predictor of recurrence was age ≥65 years, and an antibody-mediated immune response to toxin B appears to be protective against rCDI.
  
  
  
  Our findings demonstrate the importance of clinical as well as immunological risk factors in rCDI and provide more robust evidence for the protective effects of antibody to toxin B in the prevention of rCDI.
  
  
  
  NCT00350298.
authors.affiliation: Public Health and Scientific Affairs.
authors.forename: Swati B
authors.initials: SB
authors.lastname: Gupta
authors.affiliation: Pharmacoepidemiology, Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Vinay
authors.initials: V
authors.lastname: Mehta
authors.affiliation: Division of Infectious Diseases, Washington University School of Medicine, St Louis, Missouri.
authors.forename: Erik R
authors.initials: ER
authors.lastname: Dubberke
authors.affiliation: Translational Molecular Biomarkers.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Zhao
authors.affiliation: Clinical Research, Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Mary Beth
authors.initials: MB
authors.lastname: Dorr
authors.affiliation: Clinical Research, Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: Dalya
authors.initials: D
authors.lastname: Guris
authors.affiliation: Department of Pediatrics, University of Massachusetts Medical School, Worcester.|MassBiologics, Boston.
authors.forename: Deborah
authors.initials: D
authors.lastname: Molrine
authors.affiliation: MassBiologics, Boston.|Department of Medicine, University of Massachusetts Medical School, Worcester.
authors.forename: Mark
authors.initials: M
authors.lastname: Leney
authors.affiliation: Office of Medical and Scientific Affairs.
authors.forename: Mark
authors.initials: M
authors.lastname: Miller
authors.affiliation: Medical Diagnostics Discovery Department, bioMérieux, Marcy L'Etoile, France.
authors.forename: Marilyne
authors.initials: M
authors.lastname: Dupin
authors.affiliation: Pharmacoepidemiology, Merck & Co, Inc, Kenilworth, New Jersey.
authors.forename: T Christopher
authors.initials: TC
authors.lastname: Mast
mesh_terms: D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D001426:Bacterial Proteins / Q000276:immunology*; D001427:Bacterial Toxins / Q000276:immunology*; D016360:Clostridioides difficile / Q000276:immunology*; D004761:Enterocolitis, Pseudomembranous / Q000453:epidemiology / Q000276:immunology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012307:Risk Factors
chemical_list: D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D001427:Bacterial Toxins; C031815:toxB protein, Clostridium difficile
keywords: antibodies; epidemiology; risk factors; serology; toxin A