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Effect of Endogenous Clostridioides difficile Toxin Antibodies on Recurrence of C. difficile Infection.
Kelly, Ciarán P; Poxton, Ian R; Shen, Judong; Wilcox, Mark H; Gerding, Dale N; Zhao, Xuemei; Laterza, Omar F; Railkar, Radha; Guris, Dalya; Dorr, Mary Beth.
Afiliação
  • Kelly CP; Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
  • Poxton IR; University of Edinburgh, Edinburgh, United Kingdom.
  • Shen J; Merck & Co., Inc., Kenilworth, New Jersey.
  • Wilcox MH; Leeds Teaching Hospitals and University of Leeds, United Kingdom.
  • Gerding DN; Loyola University Chicago Stritch School of Medicine, Maywood.
  • Zhao X; Edward Hines Jr Veterans Affairs Hospital, Hines, Illinois.
  • Laterza OF; Merck & Co., Inc., Kenilworth, New Jersey.
  • Railkar R; Merck & Co., Inc., Kenilworth, New Jersey.
  • Guris D; Merck & Co., Inc., Kenilworth, New Jersey.
  • Dorr MB; Merck & Co., Inc., Kenilworth, New Jersey.
Clin Infect Dis ; 71(1): 81-86, 2020 06 24.
Article em En | MEDLINE | ID: mdl-31628838
BACKGROUND: Endogenous antibodies (eAbs) against Clostridioides (Clostridium) difficile toxins may protect against recurrence of C. difficile infection (rCDI). This hypothesis was tested using placebo group data from MODIFY (Monoclonal Antibodies for C. difficile Therapy) I and II (NCT01241552 and NCT01513239, respectively), global, randomized phase 3 trials that assessed the efficacy and safety of the antitoxin monoclonal antibodies bezlotoxumab and actoxumab in participants receiving antibiotic therapy for CDI. METHODS: A placebo infusion (normal saline) was administered on study day 1. Serum samples were collected on day 1, week 4, and week 12, and eAb-A and eAb-B titers were measured by 2 validated electrochemiluminescence immunoassays. Rates of initial clinical cure and rCDI were summarized by eAb titer category (low, medium, high) at each time point. RESULTS: Serum eAb titers were available from a total of 773 participants. The proportion of participants with high eAb-A and eAb-B titers increased over time. Rates of initial clinical cure were similar across eAb titer categories. There was no correlation between eAb-A titers and rCDI rate at any time point. However, there was a negative correlation between rCDI and eAb-B titer on day 1 and week 4. rCDI occurred in 22% of participants with high eAb-B titers at baseline compared with 35% with low or medium titers (P = .015). CONCLUSIONS: Higher eAb titers against toxin B, but not toxin A, were associated with protection against rCDI. These data are consistent with the observed efficacy of bezlotoxumab, and lack of efficacy of actoxumab, in the MODIFY trials. CLINICAL TRIALS REGISTRATION: NCT01241552 and NCT01513239.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Antitoxinas / Clostridioides difficile / Infecções por Clostridium Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Antitoxinas / Clostridioides difficile / Infecções por Clostridium Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article