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Efficacy, Safety and Tolerability of Cadazolid in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01222702
First received: October 8, 2010
Last updated: June 9, 2017
Last verified: June 2017
  Purpose
Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.

Condition Intervention Phase
Clostridium Difficile Infection Drug: Cadazolid Drug: Vancomycin Drug: Placebo-matching cadazolid Drug: Placebo-matching vancomycin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) 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 rate at test-of-cure [ Time Frame: Day 13 or 24-72 hours after end of treatment ]

    Percentages of subjects with clinical cure are calculated, with clinical cure being defined as resolution of diarrhea with no further Clostridium Difficile-associated diarrhea (CDAD) treatment required at test-of-cure (TOC) visit.

    Resolution of diarrhea was defined as the occurrence of ≤ 2 semi-formed or formed stools during 24 h for at least 2 consecutive 24 h periods.



Secondary Outcome Measures:
  • Recurrence rate [ Time Frame: Between Day 13 and Day 41 (within 4 weeks after end of treatment) ]
    Percentages of subjects with recurrence are calculated, with recurrence being defined as the occurrence of diarrhea (> 3 liquid or unformed stools within 24 h associated with positive C. difficile toxin A/B assay) within 4 weeks after EOT in subjects clinically cured (at test-of-cure).

  • Sustained cure rate [ Time Frame: Between Day 13 and day 41 (within 4 weeks after end of treatment) ]
    Percentages of subjects with sustained cure are calculated, with sustained cure being defined as clinical cure without CDAD recurrence up to the end of study

  • Time to resolution of diarrhea [ Time Frame: From Day 1 up to Day 13 (or 24-72 hours after end of treatment) ]
    Time to resolution of diarrhea was defined as the time (h) from the first intake of study treatment to the time (occurrence) of the first stool meeting the criteria for resolution of diarrhea up to test-of-cure.

  • Incidence of treatment-emergent adverse events [ Time Frame: From Day 1 to Day 14 ]
    Percentage of subjects with any adverse events in each group from first study treatment intake up to 3 days after last study drug intake

  • Adverse events leading to premature discontinuation of study treatment [ Time Frame: Up to Day 10 ]
    Number of patients in each group who discontinued the study treatment due to an adverse event


Other Outcome Measures:
  • Modified clinical cure rate [ Time Frame: Day 13 or 24-72 hours after end of treatment ]
    Percentage of subjects with modified clinical cure (mCC) is reported, with mCC defined as the occurrence of ≤ 3 liquid or unformed stools and any number of semi-formed or formed stools per day for at least two consecutive days, and thereafter maintained up to TOC visit. In addition, no concomitant medication active against CDAD received from the start of study treatment up to TOC


Enrollment: 84
Actual Study Start Date: January 25, 2011
Study Completion Date: November 12, 2012
Primary Completion Date: October 16, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cadazolid 250 mg
Subjects received 250 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Drug: Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Other Name: ACT-179811
Drug: Placebo-matching vancomycin
Placebo of vancomycin capsules
Experimental: Cadazolid 500 mg
Subjects received 500 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Drug: Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Other Name: ACT-179811
Drug: Placebo-matching vancomycin
Placebo of vancomycin capsules
Experimental: Cadazolid 1000 mg
Subjects received 1000 mg of reconstituted cadazolid suspension twice daily and one placebo-matching vancomycin capsule four times daily for 10 days
Drug: Cadazolid
Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
Other Name: ACT-179811
Drug: Placebo-matching vancomycin
Placebo of vancomycin capsules
Active Comparator: Vancomycin 125 mg
Subjects received one vancomycin capsule (125 mg) four times daily and reconstituted placebo-matching cadazolid suspension twice daily for 10 days
Drug: Vancomycin
Vancomycin, provided as capsules (125 mg) for oral administration
Other Name: Vancomycin hydrochloride
Drug: Placebo-matching cadazolid
Placebo of cadazolid powder for oral suspension

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male or female
  • At least 18 years of age
  • With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.

Key Exclusion Criteria:

  • Concurrent life threatening condition.
  • Immuno-compromised subjects, concomittant immuno-suppresive treatment.
  • Concomitant antimicrobial treatment for CDAD.
  • Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject 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: NCT01222702

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

Publications:
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01222702     History of Changes
Other Study ID Numbers: AC-061A201
Study First Received: October 8, 2010
Last Updated: June 9, 2017

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

Keywords provided by Actelion:
CDIFF
CDAD
CDI
Clostridium difficile infection

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 21, 2017