Clostridium DifficilePhase 4NCT02355938
Use Of Oral Fidaxomicin Vs. Oral Vancomycin For Clostridium Difficile Infection In Patients With Spinal Cord Injury
A Phase 4 study testing Fidaxomicin 200 mg and Vancomycin in people with Clostridium Difficile and Spinal Cord Injury, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile, Spinal Cord Injury
- What is being tested?
- Fidaxomicin 200 mg 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
- 1 siteUnited States
- Study dates
- Feb 2014to Oct 2016
- 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
- Ability of subject to provide an informed consent
- Legally Authorized Representative-Adult must provide consent in case the subject is unable to consent
- Diagnosis of Clostridium difficile disease based on clinical manifestations (change in bowel habits, at least 2 more unformed bowel movements as compared to baseline neurogenic bowel function in the same patient in the 24-hour period prior to randomization)
- Lab data (positive polymerase chain reaction test for Clostridium difficile in a stool specimen obtained within 72 hours before randomization)
- Patient has not received antibiotics that are active against Clostridium difficile for any more than 24 hours prior to being screened for this study.
Who cannot join
- Receipt of agents (oral Vancomycin, oral or IV Metronidazole, oral rifamdin, oral bacitracin, or oral fusidic acid) that are active against Clostridium difficile for longer than 24 hours after randomization
- Life-threatening or fulminant Clostridium difficile infection, presence of toxic megacolon, and history of inflammatory bowel disease (Crohn's disease and ulcerative colitis)
- Allergy to study medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Role of Fidaxomicin in a Patient Population With Problematic Clostridium Difficile Infection
The primary purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall costs of treatment of Clostridium difficile infection in the two study groups.
Read the detailed description
In recent clinical trials, comparing oral Vancomycin versus oral Fidaxomicin to treat Clostridium difficile, oral Fidaxomicin was shown to be the same in effectiveness as oral Vancomycin, but showed a decrease in recurrence of Clostridium difficile by ten percentage points. Based on experience with patients in our 40-bed spinal cord injury unit at the Michael E. DeBakey VA Medical Center (MEDVAMC), Clostridium difficile infection is more problematic in patients with spinal cord injury than in the general hospitalized patient population. Compared to the general population of hospitalized patients, patients with spinal cord injury are more likely to have: (1) a higher transmission of Clostridium difficile from one patient to another often via the health care worker due to their having a neurogenic bowel (2) a longer and more complicated course of Clostridium difficile infection-associated diarrhea since neurogenic bladder may delay excretion of toxins and predispose to bowel accidents; and (3) a higher overall cost of treatment in terms of extended hospitalization (most patients with spinal cord injury who suffer from Clostridium difficile infection do not get discharged from the hospital until the symptoms of course of Clostridium difficile infection are resolved. Fidaxomicin is the first in a new class of narrow spectrum macrocyclic antibiotic drugs. It is a non-systemic, meaning it is minimally absorbed into the bloodstream, and it is bactericidal, meaning it attacks and kills the bacteria it comes in contact with. It has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the numerous species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of recurrence of a Clostridium difficile infection. Since clearance of Clostridium difficile infections is problematic in the spinal cord injured patients, this antimicrobial agent may show a trend for clinical superiority and a reduction in recurrence of infection within the spinal cord injury population resulting in a shorter hospital stays and reduced costs.
- Conditions
- Clostridium Difficile, Spinal Cord Injury
- Being tested
- Fidaxomicin 200 mg, Placebo, Vancomycin
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fidaxomicin 200 mgDrug
Also called Dificid
Fidaxomicin 200 mg every 12 hours
PlaceboDrug
Also called Cellulose Capsule
1 dose of placebo every 6 hours x 2 doses
VancomycinDrug
Also called Vancocin
Vancomycin 125 mg every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Fidaxomicin Arm | Experimental | Oral Fidaxomicin 200 mg every 12 hours (Placebo for 2 doses) for 10 days Receives: Drug: Fidaxomicin 200 mg; Drug: Placebo |
| Vancomycin Arm | Active comparator | Oral Vancomycin 125 mg every 6 hours for 10 days Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of Clostridium Difficile
Decrease in number and frequency of loose stools
Measured: 10 Days
Secondary outcomes (1)
Cost Benefit Analysis
Measured: Hospitalization cost 6 months before and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Lost funding due to low 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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Principal investigator, Rabih Darouiche, Baylor College of Medicine
- Investigators
- Rabih O Darouiche, MD, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355938
- Sponsor's protocol ID
- IIS-000116
- Other IDs
- H-32358
- Status last verified
- Oct 2016
- First submitted
- 30 Jan 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Enrollment to low for statistical analysis.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fidaxomicin in a Patient Population With Problematic Clostridium Difficile Infection
- ClinicalTrials.gov ID
- NCT02355938
- Acronym / sponsor ID
- IIS-000116
- Conditions
- Clostridium Difficile, Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lost funding due to low enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- Feb 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Feb 2015 (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 purpose of this study is to compare the clinical outcomes of cure and recurrence of Clostridium difficile infection in spinal cord injured patients who are treated with oral Fidaxomicin vs. oral Vancomycin. The secondary aim of this study is to compare the overall costs of treatment of Clostridium difficile infection in the two study groups.
Detailed description
In recent clinical trials, comparing oral Vancomycin versus oral Fidaxomicin to treat Clostridium difficile, oral Fidaxomicin was shown to be the same in effectiveness as oral Vancomycin, but showed a decrease in recurrence of Clostridium difficile by ten percentage points. Based on experience with patients in our 40-bed spinal cord injury unit at the Michael E. DeBakey VA Medical Center (MEDVAMC), Clostridium difficile infection is more problematic in patients with spinal cord injury than in the general hospitalized patient population. Compared to the general population of hospitalized patients, patients with spinal cord injury are more likely to have: (1) a higher transmission of Clostridium difficile from one patient to another often via the health care worker due to their having a neurogenic bowel (2) a longer and more complicated course of Clostridium difficile infection-associated diarrhea since neurogenic bladder may delay excretion of toxins and predispose to bowel accidents; and (3) a higher overall cost of treatment in terms of extended hospitalization (most patients with spinal cord injury who suffer from Clostridium difficile infection do not get discharged from the hospital until the symptoms of course of Clostridium difficile infection are resolved. Fidaxomicin is the first in a new class of narrow spectrum macrocyclic antibiotic drugs. It is a non-systemic, meaning it is minimally absorbed into the bloodstream, and it is bactericidal, meaning it attacks and kills the bacteria it comes in contact with. It has demonstrated selective eradication of pathogenic Clostridium difficile with minimal disruption to the numerous species of bacteria that make up the normal, healthy intestinal flora. The maintenance of normal physiological conditions in the colon can reduce the probability of recurrence of a Clostridium difficile infection. Since clearance of Clostridium difficile infections is problematic in the spinal cord injured patients, this antimicrobial agent may show a trend for clinical superiority and a reduction in recurrence of infection within the spinal cord injury population resulting in a shorter hospital stays and reduced costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fidaxomicin Arm | Experimental | Drug: Fidaxomicin 200 mg, Drug: PlaceboOral Fidaxomicin 200 mg every 12 hours (Placebo for 2 doses) for 10 days |
| Vancomycin Arm | Active comparator | Drug: VancomycinOral Vancomycin 125 mg every 6 hours for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability of subject to provide an informed consent
- Legally Authorized Representative-Adult must provide consent in case the subject is unable to consent
- Diagnosis of Clostridium difficile disease based on clinical manifestations (change in bowel habits, at least 2 more unformed bowel movements as compared to baseline neurogenic bowel function in the same patient in the 24-hour period prior to randomization)
- Lab data (positive polymerase chain reaction test for Clostridium difficile in a stool specimen obtained within 72 hours before randomization)
- Patient has not received antibiotics that are active against Clostridium difficile for any more than 24 hours prior to being screened for this study.
Key exclusion criteria (3 listed)
- Receipt of agents (oral Vancomycin, oral or IV Metronidazole, oral rifamdin, oral bacitracin, or oral fusidic acid) that are active against Clostridium difficile for longer than 24 hours after randomization
- Life-threatening or fulminant Clostridium difficile infection, presence of toxic megacolon, and history of inflammatory bowel disease (Crohn's disease and ulcerative colitis)
- Allergy to study medications.
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 |
|---|---|---|
| Fidaxomicin 200 mgAlso: DificidFidaxomicin 200 mg every 12 hours | Drug | Fidaxomicin Arm |
| PlaceboAlso: Cellulose Capsule1 dose of placebo every 6 hours x 2 doses | Drug | Fidaxomicin Arm |
| VancomycinAlso: VancocinVancomycin 125 mg every 6 hours | Drug | Vancomycin Arm |
Primary outcome
Cure of Clostridium Difficile
Time frame: 10 Days
Decrease in number and frequency of loose stools
1 secondary outcome
Cost Benefit Analysis
Time frame: Hospitalization cost 6 months before and 6 months after treatment
Results and safety
The study was stopped early (reason given: Lost funding due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Individual participant dataSharing planned: No. Enrollment to low for statistical analysis.
Related trials for Clostridium Difficile
Not yet recruitingObservational study
Epidemiology of Clostridioides Difficile Infection (CDI) in Long-term Care Facilities, Assessment of Professional Practices Related to CDI Risk Prevention, and Strategies for Improving Care.
Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Rabih O Darouiche, MD principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fidaxomicin 200 mg and Vancomycin in people with Clostridium Difficile and Spinal Cord Injury, run by Baylor College of Medicine at 1 site in United States.
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 5 inclusion and 3 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 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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: Lost funding due to low 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?
Cure of Clostridium Difficile (time frame: 10 Days). 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 Oct 2016.