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

NCT01775397 | Terminated Phase 4 DMC

• 2 other identifiers: FID-EC-00012012-000531-88
• Study Type: interventional
• Target: 12
• Locations: 7 countries
• Sites: 16

Brief 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.

Conditions

Clostridium Difficile

Keywords

Dificid; Infections; Clostridium; Transplantation; Efficacy; Adult; Stem Cells; Fidaxomicin; Difficile; Immunosuppression; Vancomycin

Outcome Measures

Primary Outcomes (1)

• Sustained clinical cure of CDI at day 26

  Clinical cure is defined as a subject that at TOC no further CDI therapy is required since completion of study medication, and has either: * ≤3 unformed bowel movements for two consecutive days * ≥50% reduction in the number of unformed bowel movements compared to baseline; or * 75% reduction in the volume of liquid stool collected or no longer passing liquid stools (for subjects having rectal collection device)

  Day 26

Secondary Outcomes (9)

• Clinical Cure of CDI

  Day 12

• Sustained Clinical Cure of CDI at day 40

  Day 40

• Microbial Eradication

  Day 12

• Resolution of diarrhea

  Day 12

• Use of further CDI therapy required

  Between Day 10 and Day 12

Study Arms (2)

Fidaxomicin

EXPERIMENTAL

Fidaxomicin with alternating matching placebo

Drug: Fidaxomicin; Drug: Placebo

Vancomycin

ACTIVE COMPARATOR

Participants received 4 doses (1 dose every 6 hours) of oral vancomycin hydrochloride each day for the duration of the 10-day treatment period

Drug: Vancomycin

Interventions

Fidaxomicin DRUG

capsule

Also known as: Dificlir®

Fidaxomicin

Vancomycin DRUG

capsule

Also known as: Vancocin®

Vancomycin

Placebo DRUG

Capsule

Fidaxomicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead
• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): collaborator

Study Sites (16)

Univ. Klinik für Innere Medizi

Salzburg, 5020, Austria

Location

Herlev University Hospital

Herlev, 2730, Denmark

Location

Institut Curie

Paris, 75005, France

Location

Hôpital Necker

Paris, 75743, France

Location

Charité

Berlin, 10117, Germany

Location

Klinik I für Innere Medizin

Cologne, 50937, Germany

Location

Universitätsklinikum

Essen, 45417, Germany

Location

Universitätsklinikum Halle

Halle, 6097, Germany

Location

General Hospital of Athens

Athens, 10675, Greece

Location

Laiko General Hospital

Athens, 11527, Greece

Location

University Hospital of Crete

Heraklion, 70013, Greece

Location

Metaxa Anticancer Hospital

Piraeus, 18537, Greece

Location

Szpital Specjalistyczny w Brzo

Brzozów, 36-200, Poland

Location

H. U. de Bellvitge

Barcelona, 08907, Spain

Location

H.U. Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Infections

Interventions

Fidaxomicin; Vancomycin

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Polyketides; Macrocyclic Compounds; Polycyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Associate Director Medical Affairs

  Astellas Pharma Europe Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: January 25, 2013
• Study Start: November 29, 2012
• Primary Completion: April 15, 2013
• Study Completion: April 15, 2013
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

AU (1); DK (1); FR (2); PL (1); ES (3); DE (4); GR (4)