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ACT-179811 in Patients With Clostridium Difficile Infection (CDI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01222702
First received: October 8, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

Subjects with Clostridium Difficile Infection (CDI) are randomized and then treated with study drug 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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety & Tolerability of 3 Doses of ACT-179811 in Subjects With Clostridium Difficile Infection

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Clinical cure rate after treatment of ACT-179811. [ Time Frame: Up to 10 days treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease recurrence rate following treatment with ACT-179811. [ Time Frame: In average 4 weeks after end of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 84
Study Start Date: December 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cadazolid (ACT-179811) 250 mg bid Drug: cadazolid
cadazolid (250 mg, 500 mg or 1000 mg), or matching placebo (in the treatment group receiving vancomycin) administered orally twice daily.
Other Name: ACT-179811
Experimental: cadazolid (ACT-179811) 500 mg bid Drug: cadazolid
cadazolid (250 mg, 500 mg or 1000 mg), or matching placebo (in the treatment group receiving vancomycin) administered orally twice daily.
Other Name: ACT-179811
Experimental: cadazolid (ACT-179811) 1000 mg bid Drug: cadazolid
cadazolid (250 mg, 500 mg or 1000 mg), or matching placebo (in the treatment group receiving vancomycin) administered orally twice daily.
Other Name: ACT-179811
Active Comparator: vancomycin 125 mg qid Drug: vancomycin
Vancomaycin 125 mg, or matching placebo (in the three treatment groups receiving cadazolid) administered orally four times daily.
Other Name: vancomycin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male or female
  • at least 18 year old
  • CDI 1st occurrence or 1st recurrence

Exclusion Criteria:

  • concurrent life threatening condition
  • concomitant antimicrobial treatment for CDI
  • concomitant treatment with another investigational drug.
  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: NCT01222702

  Show 23 Study Locations
Sponsors and Collaborators
Actelion
Investigators
Study Director: Pascal Charef, DVM Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01222702     History of Changes
Other Study ID Numbers: AC-061A201
Study First Received: October 8, 2010
Last Updated: December 16, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
CDIFF
CDI
CDAD
Clostridium difficile infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014