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A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System (FREEDOM)

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ClinicalTrials.gov Identifier: NCT01775397
Recruitment Status : Terminated (Study terminated due to difficulty in enrollment)
First Posted : January 25, 2013
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Cubist Pharmaceuticals LLC
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

Tracking Information
First Submitted Date  ICMJE January 8, 2013
First Posted Date  ICMJE January 25, 2013
Last Update Posted Date June 4, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
Sustained clinical cure of CDI at day 26 [ Time Frame: Day 26 ]
Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either:
  • ≤3 unformed bowel movements for two consecutive days
  • ≥50% reduction in the number of unformed bowel movements compared to baseline; or
  • 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01775397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2013)
  • Clinical Cure of CDI [ Time Frame: Day 12 ]
    Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either:
    • ≤3 unformed bowel movements for two consecutive days
    • ≥50% reduction in the number of unformed bowel movements compared to baseline; or
    • 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
  • Sustained Clinical Cure of CDI at day 40 [ Time Frame: Day 40 ]
    Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either:
    • ≤3 unformed bowel movements for two consecutive days
    • ≥50% reduction in the number of unformed bowel movements compared to baseline; or
    • 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)
  • Microbial Eradication [ Time Frame: Day 12 ]
    Total viable count of clostridium difficile recovered from fecal specimen is below the limit of detection
  • Resolution of diarrhea [ Time Frame: Day 12 ]
    First of two days with <3 bowel movements per day
  • Use of further CDI therapy required [ Time Frame: Between Day 10 and Day 12 ]
  • Number of unformed stools [ Time Frame: Between Day 10 and Day 12 ]
  • >50% reduction in number of unformed stools compared to baseline [ Time Frame: Day 1 to Day 12 ]
  • Recurrence of CDI [ Time Frame: Between Day 1 and Day 40 ]
    After TOC, re-establishment of diarrhea to an extent that is greater than the frequency recorded on the last day of study medication
  • Time to recurrence of CDI [ Time Frame: Between Day 12 and Day 40 ]
    Time elapsing (days) from TOC to confirmed recurrence of CDI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System
Official Title  ICMJE A Phase IIIb/IV Randomized, Controlled, Double-blind, Double-dummy, Parallel Group Study to Compare the Efficacy of Fidaxomicin to Vancomycin in the Sustained Clinical Cure of Clostridium Difficile Infection in Adults Receiving Immunosuppressive Therapy
Brief Summary The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy.
Detailed Description

On Day 1, subjects with diarrhea defined as having three or more unformed bowel movements or >200 mL of unformed stool (for subjects having rectal collection devices) within 24 hours, confirmed by a rapid CDI test (positive for both toxins A & B and glutamate dehydrogenase) to have CDI will be randomized to receive fidaxomicin or vancomycin (1:1 randomization).

Subjects will be treated with study medication from Day 1 to Day 10. Assessment for clinical cure (Test of Cure [TOC]) will take place 48 - 72 hours after End of Treatment (EOT). Subjects not meeting the definition of clinical cure at TOC will be defined as treatment failures.

A stool sample for evaluation of microbial cure will be taken at TOC on Day 12. Subjects meeting the criteria for clinical cure at TOC will be monitored for recurrence until 28 days after TOC (Day 40).

Treatment of subjects with recurrence of CDI will be at the discretion of the Investigator. Subjects not meeting the criteria for clinical cure at TOC will be followed for safety until Day 40. Further CDI treatment will be at the discretion of the Investigator.

The strain of Clostridium difficile will be determined for all samples.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile
Intervention  ICMJE
  • Drug: Fidaxomicin
    capsule
    Other Name: Dificlir®
  • Drug: Vancomycin
    capsule
    Other Name: Vancocin®
  • Drug: Placebo
    Capsule
Study Arms  ICMJE
  • Experimental: Fidaxomicin
    Fidaxomicin with alternating matching placebo
    Interventions:
    • Drug: Fidaxomicin
    • Drug: Placebo
  • Active Comparator: Vancomycin
    Intervention: Drug: Vancomycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 17, 2013)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2013)
640
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CDI is confirmed by clinical symptoms and rapid CDI test
  • Subject has not been treated with medication for CDI within the last 10 days
  • Subject is:

    • receiving immunosuppressive therapy (chemotherapy) or is undergoing a stem cell transplant procedure (defined as the time period from the start of conditioning prior to transplant until 6 months after infusion of stem cells) for a hematological malignancy; or
    • receiving immunosuppressive therapy (chemotherapy) for a solid tumor malignancy or following solid organ transplantation; or
    • being treated with immunosuppressive and /or anti-TNF therapy for an auto-immune disease
  • Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study
  • Male and female subjects that are sexually active must agree to practice effective birth control during the study and for 30 days after the end of the study

Exclusion Criteria:

  • The subject has experienced more than one previous episode of CDI within the 3 months prior to study inclusion
  • Taking or requiring to be treated with prohibited medications
  • Unable to take oral study medication
  • Female patients that are pregnant, intend to become pregnant or are breastfeeding
  • History of ulcerative colitis or Crohn's disease
  • History or diagnosis of toxic megacolon or pseudomembranous colitis
  • Hypersensitivity to fidaxomicin or any of its components
  • Hypersensitivity to vancomycin or any of its components
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   France,   Germany,   Greece,   Poland,   Spain
Removed Location Countries Belgium,   Finland,   Hungary,   Italy,   Russian Federation,   Sweden,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01775397
Other Study ID Numbers  ICMJE FID-EC-0001
2012-000531-88 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )
Study Sponsor  ICMJE Astellas Pharma Europe Ltd.
Collaborators  ICMJE Cubist Pharmaceuticals LLC
Investigators  ICMJE
Study Director: Associate Director Medical Affairs Astellas Pharma Europe Ltd.
PRS Account Astellas Pharma Inc
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP