Trial record 5 of 20 for:    CDAD AND VANCOMYCIN

Clinical Study to Compare the 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 March 2016 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01987895
First received: November 7, 2013
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
Subjects with CDAD are randomized and then treated with cadazolid for 10 days. At the end of treatment, cure is assessed; subjects are then followed-up to assess any disease recurrence.

Condition Intervention Phase
Clostridium Difficile Infection
Drug: Cadazolid
Drug: Vancomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: AC-061A301, 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 at End of Treatment [ 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 ]
    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: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cadazolid
Cadazolid 250 mg bid or matching placebo granules
Drug: Cadazolid
Cadazolid 250 mg or matching placebo oral suspension twice daily.
Other Name: ACT-179811
Active Comparator: Vancomycin
Vancomycin 125 mg qid or matching placebo capsules
Drug: Vancomycin
Oral vancomycin 125 mg or matching placebo capsules 4 times daily.

Detailed Description:
An interventional study to investigate the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
  Eligibility

Ages Eligible for Study:   18 Years and older
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: NCT01987895

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

  Show 107 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Paul McGovern, MD Actelion
  More Information

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01987895     History of Changes
Other Study ID Numbers: AC-061A301 
Study First Received: November 7, 2013
Last Updated: March 22, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Peru: Instituto Nacional de Salud
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: The Italian Medicines Agency
Brazil: National Health Surveillance Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Canada: Health Canada

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms
Signs and Symptoms, Digestive
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016