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UBMD Physicians' Group

Clinical Trials

A Multi-center, Randomized, Double-blind Study to Compare the Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea (CDAD).

Subjects with CDAD are randomized and then treated with study drug for 10 days. At the end of treatment, cure is assessed; subjects are then followed-up to assess any disease recurrence.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria


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

Investigator

Alyssa Shon, M.D.

Contact Information

Name: Alyssa Shon, MD
Phone: 898-4119
Email: alyssash@buffalo.edu