Population Pharmacokinetics and Pharmacodynamics of Bezlotoxumab in Adults with Primary and Recurrent Clostridium difficile Infection
Author(s) -
Ka Lai Yee,
Huub Jan Kleijn,
Thomas Kerbusch,
Randolph P. Matthews,
Marcus Dörr,
Kevin W. Garey,
Rebecca E. Wrishko
Publication year - 2018
Publication title -
antimicrobial agents and chemotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.07
H-Index - 259
eISSN - 1070-6283
pISSN - 0066-4804
DOI - 10.1128/aac.01971-18
Subject(s) - clostridium difficile , medicine , pharmacodynamics , clostridioides , pharmacokinetics , population , clostridium infections , clostridium , microbiology and biotechnology , antibiotics , biology , bacteria , genetics , environmental health
The fully human monoclonal antibody bezlotoxumab is indicated for preventing the recurrence ofClostridioides difficile (formerlyClostridium difficile ) infection (CDI) in adults who receive antibacterial treatment for CDI and who are at high risk for a CDI recurrence. The efficacy and safety of 10-mg/kg of body weight bezlotoxumab were demonstrated in two phase 3 trials: the MODIFY I (ClinicalTrials.gov registration number NCT01241552) and MODIFY II (ClinicalTrials.gov registration number NCT01513239) trials.
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