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
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:
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014