Clostridium difficile-associated diarrhea (CDAD) MedDRA version: 19.0 Level: PT Classification code 10054236 Term: Clostridium difficile infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
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 unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive C. difficile GDH and toxin test on the same stool sample produced within 72 hours prior to randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 411 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 219
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 or known positive diagnostic test for enteropathogens. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the clinical response after 10-day oral administration of cadazolid is non-inferior to oral vancomycin in subjects with CDAD.;Secondary Objective: To determine whether oral administration of cadazolid for 10 days is superior to oral vancomycin in the sustained clinical response of subjects with CDAD. To determine whether the resolution of diarrhea (ROD) is more rapid with oral administration of cadazolid compared to vancomycin. To determine whether CDAD symptoms, as reported by the subject, show larger improvements from baseline with oral administration of cadazolid compared to vancomycin.;Primary end point(s): Clinical Cure defined as: • Resolution of Diarrhea (ROD: = 3 UBMs per day for at least 2 consecutive days) on study treatment, maintained for 2 days after End of Treatment (EOT) AND • No additional antimicrobial treatment active against CDAD or FMT between first dose and 2 days after EOT (inclusive). ;Timepoint(s) of evaluation of this end point: See above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Sustained Cure defined as: • Clinical Cure AND • No Recurrence Recurrence is defined for subjects with Clinical Cure as: • New episode of diarrhea (NED: > 3 UBMs within 1 day) occurring between 3 days after EOT and Visit 5 AND • Positive C. difficile GDH and toxin stool test on the same stool sample AND • Antimicrobial treatment active against CDAD or FMT started between 3 days after EOT and Visit 5 (or participation in the re-treatment extension with cadazolid). Time to ROD, defined as: • The time (h) elapsed between the first dose of study drug and the time when ROD is considered achieved. Absolute change from baseline in CDAD DaySyms Patient Reported Outcomes (PRO). CDAD DaysSyms total daily score change from baseline up to Day 12.;Timepoint(s) of evaluation of this end point: See above | — |
Countries
Australia, Brazil, Canada, France, Germany, Italy, Netherlands, Peru, Poland, Romania, Spain, United States
Contacts
Public ContactGlobal Medical Information
Actelion Pharmaceuticals Ltd
Outcome results
None listed