Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)

This multicenter, study will be run into two parts. Both parts will be run in consecutive age
cohorts, starting from the oldest age categories(12 to < 18 years old) to the youngest (birth
to < 3 months).

- Part A is an open-label, dose finding part to be conducted in at least 24 subjects.

- Part B follows a randomized, assessor-blinded, parallel-group design with vancomycin
used as an active comparator. Part B will be conducted in about 176 children.

In both parts, the treatment period will be 10 days and will be followed by a Follow-up
period of 28-32 days.

Key Inclusion Criteria:

- Signed informed consent by parents or legally authorized representatives (LAR) and
assent by the child according to local requirements prior to initiation of any
study-mandated procedure.

- Male or female from birth to < 18 years of age, diagnosed with Clostridium
Difficile-associated diarrhea (CDAD).

- Females of childbearing potential must have a negative pregnancy test at screening and
must agree to use an adequate and reliable method of contraception.

Key Exclusion Criteria:

- Positive Rotavirus test for subjects < 5 years.

- Fulminant or life-threatening CDAD.

- More than one previous episode of CDAD in the 3 month period prior to enrollment /
randomization.

- Antimicrobial treatment active against CDAD administered within 24 h prior to
screening except for metronidazole treatment failures (MTF).

- Subjects with body weight < 3 kg.

- Inflammatory bowel disease, chronic abdominal pain, or chronic diarrhea of any
etiology.

- Fecal microbiota transplant (FMT), immunoglobulin therapy, or any investigational drug
to prevent or treat CDAD within 1 month period (or 5 half-lives in case of
investigational drug, whichever is longer) prior to enrollment / randomization.

- Monoclonal antibodies against C. difficile within 6 months prior to enrollment /
randomization.

- Previous vaccination against C. difficile.

- Known mental disorders.

- Any circumstances or conditions, which, in the opinion of the investigator, may affect
the subject's full participation in the study, or compliance with the protocol.