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
- MedDRA version: 14.1Level: PTClassification code 10061043Term: Clostridial infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Adult patients with Clostridium difficile infection who are receivingimmunosuppressive therapy.
- Registration Number
- EUCTR2012-000531-88-IT
- Lead Sponsor
- ASTELLAS PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 640
1.Subject is 18 years of age or over.
2.CDI is confirmed by clinical symptoms (see Section 5.2.3) and rapid CDI test. (see Section 5.7)
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) 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
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 whenused 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 512
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 listed in Section 5.1.3.2.
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 observation specified in the protocol.
8.Has taken an 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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to demonstrate superiority of<br>fidaxomicin versus vancomycin for the sustained clinical cure of<br>Clostridium difficile Infection (CDI) in adult patients receiving<br>immunosuppressive therapy. Sustained clinical cure is defined as clinical<br>cure without recurrence within 14 days from Test of Cure (TOC).;Secondary Objective: Secondary objectives of this study are <br>- to compare the rates of clinical cure of CDI at TOC on Day 12 and of sustained clinical cure of CDI at Day 40 after treatment with fidaxomicin or vancomycin <br>-to compare the recurrence rate of CDI after treatment with fidaxomicin or vancomycin <br>- to compare the time to resolution of diarrhea on treatment with fidaxomicin or vancomycin;Primary end point(s): The primary endpoint in this study is the rate of sustained clinical cure<br>14 days after TOC (at Day 26);Timepoint(s) of evaluation of this end point: Day 26
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A