Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Historical adult pharmacokinetic data is from NCT01241552 and NCT01513239.
Age
1–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At screening has suspected or confirmed Clostridium difficile infection (CDI), and is receiving or is planning to receive a 10- to 21-day course of antibacterial drug treatment for CDI
At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool, and is still receiving antibacterial drug treatment for CDI
Female is not pregnant, and not breastfeeding; but if of childbearing potential agrees to follow contraceptive guidance during the treatment period and for at least 12 weeks after the last dose of study treatment
Participant and/or parent or caregiver must be able to read, understand, and complete the daily diary
You may not be if
Has an uncontrolled chronic diarrheal illness
Has a known hypersensitivity to bezlotoxumab, its active substance and/or any of its excipients
At randomization, their planned course of antibacterial drug treatment for CDI is longer than 21 days
At screening has received any listed prohibited prior and concomitant treatments and procedures
Has previously participated in this study, has previously received bezlotoxumab, has received an experimental monoclonal antibody against C. difficile toxin B, or has received a vaccine directed against C. difficile or its toxins.
Has received an investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical study with an investigational agent during the 12-week study period
