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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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clostridium Difficile

Intervention: Fidaxomicin (Drug); Vancomycin (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Astellas Pharma Europe Ltd.

Official(s) and/or principal investigator(s):
Associate Director Medical Affairs, Study Director, Affiliation: Astellas Pharma Europe Ltd.

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.

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sustained clinical cure of CDI at day 26

Secondary outcome:

Clinical Cure of CDI

Sustained Clinical Cure of CDI at day 40

Microbial Eradication

Resolution of diarrhea

Use of further CDI therapy required

Number of unformed stools

>50% reduction in number of unformed stools compared to baseline

Recurrence of CDI

Time to recurrence of CDI

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Univ. Klinik für Innere Medizi, Salzburg 5020, Austria

Herlev University Hospital, Herlev 2730, Denmark

Hôpital Necker, Paris 75743, France

Institut Curie, Paris 75005, France

Charité, Berlin 10117, Germany

Universitätsklinikum, Essen 45417, Germany

Universitätsklinikum Halle, Halle 6097, Germany

Klinik I für Innere Medizin, Koln 50937, Germany

General Hospital of Athens, Athens 10675, Greece

Laiko General Hospital, Athens 11527, Greece

University Hospital of Crete, Heraklion 70013, Greece

Metaxa Anticancer Hospital, Piraeus 18537, Greece

Szpital Specjalistyczny w Brzo, Brzozów 36-200, Poland

H. U. de Bellvitge, Barcelona 08907, Spain

H.U. Gregorio Maranon, Madrid 28007, Spain

Hospital 12 de Octubre, Madrid 28041, Spain

Additional Information

Link to Results on JAPIC

Starting date: November 2012
Last updated: June 2, 2014

Page last updated: August 23, 2015

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