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

Clostridium Difficile Clinical Trial

— FREEDOM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01775397
• Other study ID #: FID-EC-0001
• Secondary ID: 2012-000531-88
• Status: Terminated
• Phase: Phase 4
• Start date: November 29, 2012
• Est. completion date: April 15, 2013

Study information

• Verified date: January 2020
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 15, 2013
• Est. primary completion date: April 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile
• Clostridium Infections
• Infection

Intervention

Drug:
• Fidaxomicin
capsule
• Vancomycin
capsule
• Placebo
Capsule

Locations

Country	Name	City	State
Austria	Univ. Klinik für Innere Medizi	Salzburg
Denmark	Herlev University Hospital	Herlev
France	Hôpital Necker	Paris
France	Institut Curie	Paris
Germany	Charité	Berlin
Germany	Universitätsklinikum	Essen
Germany	Universitätsklinikum Halle	Halle
Germany	Klinik I für Innere Medizin	Koln
Greece	General Hospital of Athens	Athens
Greece	Laiko General Hospital	Athens
Greece	University Hospital of Crete	Heraklion
Greece	Metaxa Anticancer Hospital	Piraeus
Poland	Szpital Specjalistyczny w Brzo	Brzozów
Spain	H. U. de Bellvitge	Barcelona
Spain	H.U. Gregorio Maranon	Madrid
Spain	Hospital 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.	Cubist Pharmaceuticals LLC

Countries where clinical trial is conducted

Austria,  Denmark,  France,  Germany,  Greece,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Cure of CDI	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 12
Secondary	Sustained Clinical Cure of CDI at day 40	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 40
Secondary	Microbial Eradication	Total viable count of clostridium difficile recovered from fecal specimen is below the limit of detection	Day 12
Secondary	Resolution of diarrhea	First of two days with <3 bowel movements per day	Day 12
Secondary	Use of further CDI therapy required		Between Day 10 and Day 12
Secondary	Number of unformed stools		Between Day 10 and Day 12
Secondary	>50% reduction in number of unformed stools compared to baseline		Day 1 to Day 12
Secondary	Recurrence of CDI	After TOC, re-establishment of diarrhea to an extent that is greater than the frequency recorded on the last day of study medication	Between Day 1 and Day 40
Secondary	Time to recurrence of CDI	Time elapsing (days) from TOC to confirmed recurrence of CDI	Between Day 12 and Day 40

External Links

•   Link to results on Astellas Clinical Study Results website