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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01987895
Registration number
NCT01987895
Ethics application status
Date submitted
7/11/2013
Date registered
20/11/2013
Date last updated
4/05/2018
Titles & IDs
Public title
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
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Scientific title
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)
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Secondary ID [1]
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AC-061A301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Clostridium Difficile Infection
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Cadazolid
Treatment: Drugs - Vancomycin
Treatment: Drugs - Cadazolid-matching placebo
Treatment: Drugs - Vancomycin-matching placebo
Experimental: Cadazolid - Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Active Comparator: Vancomycin - Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Treatment: Drugs: Cadazolid
Cadazolid 250 mg as oral suspension twice daily.
Treatment: Drugs: Vancomycin
Vancomycin 125 mg as oral capsules 4 times daily.
Treatment: Drugs: Cadazolid-matching placebo
Placebo matching cadazolid and administered orally twice daily
Treatment: Drugs: Vancomycin-matching placebo
Placebo capsules matching vancomycin and administered orally 4 times per day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Clinical Cure Rate (CCR) in the Modified Intent-to-treat Population
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Assessment method [1]
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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 modified intent-to-treat set (mITT) are reported below.
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Timepoint [1]
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Up to Day 12 on average (end-of-treatment + 2 days)
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Primary outcome [2]
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Clinical Cure Rate (CCR) in the Per-protocol Population
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Day 12 on average (end-of-treatment + 2 days)
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Secondary outcome [1]
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Sustained Cure Rate (SCR) in the Modified Intent-to-treat Population
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Assessment method [1]
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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).
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Timepoint [1]
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Between Day 38 and Day 42 on average (end-of-treatment + 28-32 days)
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Secondary outcome [2]
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Kaplan-Meier Estimates for Resolution of Diarrhea
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Day 10
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Secondary outcome [3]
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Change From Baseline to Day 3 in Clostridium Difficile Infection (CDI) Daily Symptoms Patient-Reported Outcome (CDI-DaySyms PRO) Domain Scores
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Assessment method [3]
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CDI-DaySyms PRO is a questionnaire assessing 10 symptoms relevant to subjects with CDAD and grouped into 3 domains: Diarrhea symptoms, Abdominal symptoms and Systemic/Other. The subjects rate the severity of each item as None, Mild, Moderate, Severe or Very severe, converted to numeric scores from 0 to 4, respectively. The daily domain score is calculated as the mean of the non-missing responses for that domain on that day. A negative value for change from baseline corresponds to an improvement in domain score. The three domains are evaluated in a hierarchical manner, starting with Diarrhea Symptoms, then Abdominal Symptoms, and finally Systemic/Other Symptoms. The least squares means (LSM) are computed on the scores.
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Timepoint [3]
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Day 1 (baseline) and Day 3
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/03/2014
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Date of last participant enrolment
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Actual
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Date of last data collection
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Actual
24/03/2017
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Sample size
Target
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Accrual to date
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Final
632
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigator Site - Geelong
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Recruitment hospital [2]
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Investigator Site - Southport
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Recruitment postcode(s) [1]
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3217 - Geelong
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Recruitment postcode(s) [2]
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4215 - Southport
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Recruitment outside Australia
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United States of America
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Alabama
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Funding & Sponsors
Primary sponsor type
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Ethics application status
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Summary
Brief summary
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
in subjects with Clostridium difficile-associated diarrhea (CDAD).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01987895
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Anne Claire Marrast, MD
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Actelion
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01987895
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