Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
 in subjects with Clostridium difficile-associated diarrhea (CDAD).
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