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).
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 631
- Primary Endpoint
- Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Study Overview
Brief Summary
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
Detailed Description
Subjects selected to participate in the study are treated either with cadazolid or vancomycin for 10 days. At the end of treatment, clinical cure is assessed; subjects are then followed-up to assess any disease recurrence.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Cadazolid
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Intervention: Cadazolid (Drug)
Cadazolid
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Intervention: Vancomycin-matching placebo (Drug)
Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Intervention: Vancomycin (Drug)
Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Intervention: Cadazolid-matching placebo (Drug)
Outcomes
Primary Outcomes
Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
Time Frame: Up to Day 12 on average (end-of-treatment + 2 days)
Clinical Cure is defined as: • Resolution of Diarrhea (ROD) (≤ 3 unformed bowel movement (UBM) per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant (FMT) between first dose of study drug and 2 days after EOT (inclusive). CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the modified intent-to-treat set (mITT) are reported below.
Clinical Cure Rate (CCR) in the Per-protocol Population
Time Frame: Up to Day 12 on average (end-of-treatment + 2 days)
Clinical Cure (CC) is defined as: • Resolution of Diarrhea (≤ 3 unformed bowel movement per day for at least 2 consecutive days) on study treatment and maintained for 2 days after end-of-treatment (EOT), AND • No additional antimicrobial treatment active against Clostridium difficile-associated diarrhea (CDAD) or fecal microbiota transplant between first dose of study drug and 2 days after EOT. CCR is the percentage of subjects with Clinical Cure. Analyses are performed on two analysis sets. Results on the per-protocol set (PPS) are reported below.
Secondary Outcomes
- Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population(Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days))
- Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)(Up to Day 10)
- Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores(Baseline to End of Treatment (10 days after starting study drug) + 2 days)