Phase 3
N=632
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
Clostridium Difficile Infection
Bottom Line
View on ClinicalTrials.gov: NCT01987895 ↗Enrolled (actual)
632
Serious AEs
7.2%
Results posted
May 2018
Primary outcome: Primary: Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population — 83.8; 85.2 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cadazolid (Drug); Vancomycin (Drug); Cadazolid-matching placebo (Drug); Vancomycin-matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Actelion
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population |
83.8; 85.2 | — |
| PRIMARY Clinical Cure Rate (CCR) in the Per-protocol Population |
87.6; 91.7 | — |
| SECONDARY Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population |
65.6; 62.3 | — |
| SECONDARY Kaplan-Meier Estimates for Resolution of Diarrhea |
46.7; 45.9; 62.6; 60.7; 69.9; 71.1 | 0.6016 |
| SECONDARY Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores |
-1.233; -1.235; -0.623; -0.710; -0.639; -0.689 | 0.9814 |
Summary
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
Eligibility 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.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT01987895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.