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

Inclusion Criteria:

• Signed Informed Consent.

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

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

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 formetronidazole treatment failures (MTF)

• Known hypersensitivity or contraindication to study drugs, oxazolidinones, orquinolones.

• Unable or unwilling to comply with all protocol requirements.

• Any circumstances or conditions, which, in the opinion of the investigator, mayaffect full participation in the study or compliance with the protocol