None listed
Conditions
Interventions
Drug: Cadazolid : Cadazolid 250 mg or matching placebo as granules for oral suspension to be reconstituted prior to administration twice daily.
Drug: vancomycin :Oral vancomycin 125 mg or matching
the capsule must be swallowed intact with or without water
Dosing scheme: Each subject will receive blinded study medication administered orally each day
subjects will take doses approximately 6 hours apart (40 doses
every 6 hours for 10 days). On adaily schedule, this corresponds approximately to study drug doses at breakfast, lunch, late afternoon (dinner) and bedtime. Study drug can be taken with or without foo
Sponsors
Actelion Pharmaceuticals Ltd,
Eligibility
Age
18 Years to 99 Years
Inclusion 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 (by enzyme immunoassay approved by the sponsor) on a stool sample produced within 72 hours prior to randomization.
Exclusion criteria
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. Inability to take oral medication, or subjects with feeding tubes. Antimicrobial treatment active against CDAD administered for > 24 hours except for metronidazole treatment failures (MTF). Planned treatment with forbidden concomitant medications. Fecal microbiota transplant (FMT), immunoglobulin therapy, and investigational drug to prevent or treat CDAD within 1 month prior to randomization Monoclonal antibodies against C. difficile within 6 months prior to randomization. Previous vaccination against C. difficile. Previous participation in a clinical trial with cadazolid. Known hypersensitivity or contraindication to study drugs, oxazolidinones, or quinolones. Females who are breastfeeding. Investigational site staff members or relatives, and Actelion employees. Unable or unwilling to comply with all protocol requirements.
Countries
Australia, Brazil, Canada, China, France, Germany, Italy, Korea South, Netherlands, New Zealand, Peru, Poland, Romania, Spain, Taiwan, United Kindgdom, United States
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed