Clostridium DifficilePhase 4FREEDOMNCT01775397
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
A Phase 4 study testing Fidaxomicin and Vancomycin in people with Clostridium Difficile, run by Astellas Pharma Europe Ltd. at 16 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Fidaxomicin and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 29 Nov 2012to 15 Apr 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Germany4 sites
Charité
Berlin, 10117
Klinik I für Innere Medizin
Cologne, 50937
Universitätsklinikum
Essen, 45417
Universitätsklinikum Halle
Halle, 6097
Greece4 sites
General Hospital of Athens
Athens, 10675
Laiko General Hospital
Athens, 11527
University Hospital of Crete
Heraklion, 70013
Metaxa Anticancer Hospital
Piraeus, 18537
Spain3 sites
H. U. de Bellvitge
Barcelona, 08907
H.U. Gregorio Maranon
Madrid, 28007
Hospital 12 de Octubre
Madrid, 28041
About this study
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
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.
Read the 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.
- Conditions
- Clostridium Difficile
- Being tested
- Fidaxomicin, Vancomycin, Placebo
- Keywords
- Dificid, Infections, Clostridium, Transplantation, Efficacy, Adult, Stem Cells, Fidaxomicin, Difficile, Immunosuppression, Vancomycin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FidaxomicinDrug
Also called Dificlir®
capsule
VancomycinDrug
Also called Vancocin®
capsule
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Fidaxomicin | Experimental | Fidaxomicin with alternating matching placebo Receives: 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 Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 26
Secondary outcomes (9)
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)
Measured: Day 12
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)
Measured: Day 40
Microbial Eradication
Total viable count of clostridium difficile recovered from fecal specimen is below the limit of detection
Measured: Day 12
Resolution of diarrhea
First of two days with <3 bowel movements per day
Measured: Day 12
Use of further CDI therapy required
Measured: Between Day 10 and Day 12
Number of unformed stools
Measured: Between Day 10 and Day 12
>50% reduction in number of unformed stools compared to baseline
Measured: Day 1 to Day 12
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
Measured: Between Day 1 and Day 40
Time to recurrence of CDI
Time elapsing (days) from TOC to confirmed recurrence of CDI
Measured: Between Day 12 and Day 40
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study start29 Nov 2012
- Primary completion15 Apr 2013
- Study completion15 Apr 2013
Why it stopped: Study terminated due to difficulty in enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Sponsor
- Investigators
- Associate Director Medical Affairs, Study director, Astellas Pharma Europe Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775397
- Sponsor's protocol ID
- FID-EC-0001
- Other IDs
- 2012-000531-88
- Acronym
- FREEDOM
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2013
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01775397
- Acronym / sponsor ID
- FREEDOM / FID-EC-0001
- Conditions
- Clostridium Difficile
- Keywords
- Dificid, Infections, Clostridium, Transplantation, Efficacy, Adult, Stem Cells, Fidaxomicin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to difficulty in enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- 29 Nov 2012 (actual)
- Primary completion
- 15 Apr 2013 (actual)
- Study completion
- 15 Apr 2013 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fidaxomicin | Experimental | Drug: Fidaxomicin, Drug: PlaceboFidaxomicin with alternating matching placebo |
| Vancomycin | Active comparator | Drug: VancomycinParticipants received 4 doses (1 dose every 6 hours) of oral vancomycin hydrochloride each day for the duration of the 10-day treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FidaxomicinAlso: Dificlir®capsule | Drug | Fidaxomicin |
| VancomycinAlso: Vancocin®capsule | Drug | Vancomycin |
| PlaceboCapsule | Drug | Fidaxomicin |
Primary outcome
Sustained clinical cure of CDI at day 26
Time frame: 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)
9 secondary outcomes
Clinical Cure of CDI
Time frame: Day 12
Sustained Clinical Cure of CDI at day 40
Time frame: Day 40
Microbial Eradication
Time frame: Day 12
Resolution of diarrhea
Time frame: Day 12
Use of further CDI therapy required
Time frame: Between Day 10 and Day 12
Number of unformed stools
Time frame: Between Day 10 and Day 12
>50% reduction in number of unformed stools compared to baseline
Time frame: Day 1 to Day 12
Recurrence of CDI
Time frame: Between Day 1 and Day 40
Time to recurrence of CDI
Time frame: Between Day 12 and Day 40
Results and safety
The study was stopped early (reason given: Study terminated due to difficulty in enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Associate Director Medical Affairs study director
Astellas Pharma Europe Ltd.
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fidaxomicin and Vancomycin in people with Clostridium Difficile, run by Astellas Pharma Europe Ltd. at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Greece, Spain, France, Austria and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to difficulty in enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained clinical cure of CDI at day 26 (time frame: Day 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020; AzTrials last refreshed its copy on 7 Nov 2026.