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Trial record 7 of 21 for:    CDAD AND VANCOMYCIN

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01983683
First received: November 7, 2013
Last updated: July 1, 2016
Last verified: July 2016
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change from baseline to End of Treatment + 2 days in CDAD Symptoms as measured by the DaySyms Patient Reported Outcome (PRO)


Estimated Enrollment: 640
Study Start Date: November 2013
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Invalid value
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)
Genders Eligible for Study:   Both
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

Contacts
Contact: CTD Clinical Trials Disclosure Desk clinical-trials-disclosure@actelion.com

  Show 123 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Paul McGovern, 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: July 1, 2016
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Slovakia: State Institute for Drug Control
Greece: National Organization of Medicines
Israel: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Korea: Ministry of Food and Drug Safety
Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on September 23, 2016