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Trial record 1 of 1 for:    NCT 01983683
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Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile-associated Diarrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01983683
First received: November 7, 2013
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

Condition Intervention Phase
Clostridium Difficile Infection
Drug: Cadazolid
Drug: Vancomycin
Drug: Cadazolid-matching placebo
Drug: Vancomycin-matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official 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).

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Clinical Cure [ Time Frame: End of Treatment (10 days after starting study drug) + 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 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)


Secondary Outcome Measures:
  • Sustained Cure [ Time Frame: End of Treatment (10 days after starting study drug) + 28-32 days ]
    Sustained cure is defined for each subject having clinical cure and no recurrence.

  • Time to Resolution of Diarrhea [ Time Frame: Baseline to End of Treatment (10 days after starting study drug) ]
    The time between the first dose of study drug and Resolution of Diarrhea.

  • Absolute change from baseline in clostridium difficile-associated diarrhea (CDAD) DaySyms PRO daily score [ Time Frame: Baseline to End of Treatment (10 days after starting study drug) + 2 days ]
    Change from baseline to End of Treatment + 2 days in CDAD Symptoms as measured by the DaySyms Patient Reported Outcome (PRO)


Enrollment: 631
Actual Study Start Date: December 12, 2013
Study Completion Date: May 2, 2017
Primary Completion Date: March 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cadazolid
Subjects receive oral cadazolid 250 mg twice daily (bid) and oral vancomycin-matching placebo 4 times per day (qid) for 10 days
Drug: Cadazolid
Cadazolid 250 mg as oral suspension twice daily.
Other Name: ACT-179811
Drug: Vancomycin-matching placebo
Placebo capsules matching vancomycin and administered orally 4 times per day
Active Comparator: Vancomycin
Subjects receive oral vancomycin 125 mg qid and oral cadazolid-matching placebo bid for 10 days
Drug: Vancomycin
Vancomycin 125 mg as oral capsules 4 times daily
Other Name: Vancocin
Drug: Cadazolid-matching placebo
Placebo matching cadazolid and administered orally twice daily

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01983683

  Show 90 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Anne Claire Marrast, MD Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01983683     History of Changes
Other Study ID Numbers: AC-061A302
Study First Received: November 7, 2013
Last Updated: May 12, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Actelion:
Clostridium difficile infection
Post-antibiotic diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Oxazolidinones
Vancomycin
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 24, 2017