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

• Status: Terminated
• Trial end date: 2013-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe Ltd.
• Collaborator: Cubist Pharmaceuticals LLC
• Treatments: Fidaxomicin; Vancomycin

Criteria

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