Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

Subjects selected to participate in the study are treated either with cadazolid or vancomycin
for 10 days. At the end of treatment, clinical cure is assessed; subjects are then
followed-up to assess any disease recurrence.

Inclusion Criteria:

- Signed Informed Consent.

- Male or female ≥ 18 years of age. Females of childbearing potential must agree to use
an adequate and reliable method of contraception.

- Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first
recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid
or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive
C. difficile toxin test on a stool sample produced within 72 hours prior to
randomization.

Exclusion Criteria:

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

- Evidence of life-threatening or fulminant CDAD.

- Likelihood of death within 72 hours from any cause.

- History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.

- Antimicrobial treatment active against CDAD administered for > 24 hours except for
metronidazole treatment failures (MTF)

- Known hypersensitivity or contraindication to study drugs, oxazolidinones, or
quinolones.

- Unable or unwilling to comply with all protocol requirements.

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