Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

Phase 3CompletedNCT01983683

Actelion631 enrolled

Overview

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

631

Conditions

Clostridium Difficile Infection

Interventions

CadazolidDRUG

Cadazolid 250 mg as oral suspension twice daily.

VancomycinDRUG

Vancomycin 125 mg as oral capsules 4 times daily

Cadazolid-matching placeboDRUG

Placebo matching cadazolid and administered orally twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population

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.

Time frame: Up to Day 12 on average (end-of-treatment + 2 days)

Clinical Cure Rate (CCR) in the Per-protocol Population

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.

Time frame: Up to Day 12 on average (end-of-treatment + 2 days)

Secondary Outcomes

Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population

Sustained Cure is defined for each subject having Clinical Cure and no recurrence. SCR is the percentage of subjects with Sustained Cure. The main analysis is performed on the modified intent-to-treat set (mITT).

Time frame: Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)

Kaplan-Meier Estimates for Resolution of Diarrhea (ROD)

Resolution of Diarrhea (ROD) is defined as no more than 3 unformed bowel movements per day for at least two consecutive days for subjects on study treatment. The Kaplan-Meier estimates (KM estimates) for having an event (ROD) are reported for each time point.

Data from ClinicalTrials.gov

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