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Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection in Patients at Increased Risk for Recurrence.
- Source :
-
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2018 Aug 16; Vol. 67 (5), pp. 649-656. - Publication Year :
- 2018
-
Abstract
- Background: Bezlotoxumab is a human monoclonal antibody against Clostridium difficile toxin B indicated to prevent C. difficile infection (CDI) recurrence (rCDI) in adults at high risk for rCDI. This post hoc analysis of pooled monocolonal antibodies for C.difficile therapy (MODIFY) I/II data assessed bezlotoxumab efficacy in participants with characteristics associated with increased risk for rCDI.<br />Methods: The analysis population was the modified intent-to-treat population who received bezlotoxumab or placebo (n = 1554) by risk factors for rCDI that were prespecified in the statistical analysis plan: age ≥65 years, history of CDI, compromised immunity, severe CDI, and ribotype 027/078/244. The proportion of participants with rCDI in 12 weeks, fecal microbiota transplant procedures, 30-day all cause and CDI-associated hospital readmissions, and mortality at 30 and 90 days after randomization were presented.<br />Results: The majority of enrolled participants (75.6%) had ≥1 risk factor; these participants were older and a higher proportion had comorbidities compared with participants with no risk factors. The proportion of placebo participants who experienced rCDI exceeded 30% for each risk factor compared with 20.9% among those without a risk factor, and the rCDI rate increased with the number of risk factors (1 risk factor: 31.3%; ≥3 risk factors: 46.1%). Bezlotoxumab reduced rCDI, fecal microbiota transplants, and CDI-associated 30-day readmissions in participants with risk factors for rCDI.<br />Conclusions: The risk factors prespecified in the MODIFY statistical analysis plan are appropriate to identify patients at high risk for rCDI. While participants with ≥3 risk factors had the greatest reduction of rCDI with bezlotoxumab, those with 1 or 2 risk factors may also benefit.<br />Clinical Trials Registration: NCT01241552 (MODIFY I) and NCT01513239 (MODIFY II).
- Subjects :
- Adolescent
Adult
Age Factors
Aged
Aged, 80 and over
Broadly Neutralizing Antibodies
Clostridioides difficile drug effects
Clostridium Infections mortality
Fecal Microbiota Transplantation
Female
Fidaxomicin administration & dosage
Humans
Male
Metronidazole administration & dosage
Middle Aged
Patient Readmission
Recurrence
Risk Factors
Vancomycin administration & dosage
Young Adult
Anti-Bacterial Agents therapeutic use
Antibodies, Monoclonal therapeutic use
Antibodies, Neutralizing therapeutic use
Clostridium Infections prevention & control
Secondary Prevention
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6591
- Volume :
- 67
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
- Publication Type :
- Academic Journal
- Accession number :
- 29538686
- Full Text :
- https://doi.org/10.1093/cid/ciy171