This clinical study investigates the effect of fidaxomicin in comparison to vancomycin in adult patients with an infection of Clostridium difficile, and are using medicinal products that suppress the immune system.

• Conditions: Adult patients with Clostridium difficile infection who are receiving immunosuppressive therapy.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; MedDRA version: 15.1Level: PTClassification code 10061043Term: Clostridial infectionSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2012-000531-88-DK
• Lead Sponsor: Astellas Pharma Europe Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-18
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

A subject is eligible for the study if all of the following apply:
1. Subject is 18 years of age or over.
2. CDI is confirmed by clinical symptoms and rapid CDI test
3. Subject has not been treated with medication or other therapy for CDI within the last 10 days.
4. Subject is:
- receiving immunosuppressive therapy (chemotherapy) for a hematological malignancy 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); 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 or related illness
5. Subject has signed written informed consent.
6. Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study.
7. 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. (An effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 696
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 557

Exclusion Criteria

Subject will be excluded from participation in this study if any of the following apply:
1. The subject has experienced more than one previous episode of CDI within the 3 months prior to study inclusion.
2. Taking or requiring to be treated with prohibited medications
3. Unable to take oral study medication.
4. Female patients that are pregnant, intend to become pregnant or are breastfeeding.
5. History of ulcerative colitis or Crohn’s disease.
6. History or diagnosis of toxic megacolon or pseudomembranous colitis.
7. Not willing to adhere to the provisions of treatment and procedures specified in the protocol.
8. Has been randomised into this study previously, has taken any investigational drug within 28 days prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
9. Hypersensitivity to fidaxomicin or any of its components.
10. Hypersensitivity to vancomycin or any of its components.
11. Any clinical condition which, in the opinion of the investigator, would not allow safe completion of this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified