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