FREEDOM Study

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  110401

• Contact name

  David Marks

• Sponsor organisation

  Astellas Pharma Europe Ltd.

• Eudract number

  2012-000531-88

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This is a randomised, double-blind study which aims to compare two treatments for Clostridium difficile Infection (CDI) in adults receiving immunosuppressive therapy. CDI represents a large clinical burden and is caused by an overgrowth of Clostridium difficile in the colon. C. difficile is the leading cause of infectious hospital-acquired diarrhea in industrialized countries. The clinical burden of CDI is compounded by the fact that as many as 25% of patients will suffer a recurrence of infection within 30 days following treatment. Recurrence of CDI is a challenge with currently available treatments and finding an alternative treatment with fewer recurrence would benefit society and for the individual subject. Patients receiving immunosuppressive therapy have been shown to be at increased risk of CDI and of disease recurrence. The FREEDOM study aims to compare the efficacy and safety of Fidaxomicin (which has a narrow spectrum antibacterial profile and potent, bactericidal activity against Clostridium difficile) against the ''gold standard'' Vancomycin, in the treatment of CDI, in the specific population of patients receiving immunosuppressive therapy (i.e due to undergoing a stem cell transplant procedure; for the treatment of a malignancy; following solid organ transplantation; or for an autoimmune disease). The primary objective is to demonstrate superiority of fidaxomicin versus vancomycin for the sustained clinical cure of CDI in this patient population group. Sustained clinical cure is defined as clinical cure without recurrence within 14 days from the assessment for clinical cure: Test of Cure (TOC). The study is being conducted in Europe and in up to 3 hospitals sites in the UK. Patients with CDI who meet the eligibility criteria will be treated with study medication for 10 days. TOC will take place 48-72hours afterwards. Subjects meeting the criteria for clinical cure will be monitored for recurrence until 28 days after TOC (Day 40).

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  12/EE/0374

• Date of REC Opinion

  9 Nov 2012

• REC opinion

  Further Information Favourable Opinion