Clostridium Difficile InfectionPhase 2NCT02784002
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
A Phase 2 study testing Ridinilazole and Fidaxomicin in people with Clostridium Difficile Infection, run by Summit Therapeutics at 16 sites in 3 countries.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- Ridinilazole and Fidaxomicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Dec 2014to Aug 2016
- Phase
- Phase 2
- 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
- Informed Consent
- Clinical diagnosis of CDI plus laboratory diagnostic test
- No more than 30 hours antimicrobial treatment for current CDI episode
- Female subjects of childbearing potential must use adequate contraception
Who cannot join
- Life-threatening or fulminant CDI
- Subjects with 2 or more episodes of CDI in the previous year
- Females who are pregnant or breastfeeding
- History of inflammatory bowel disease
- Co-administration of potent P-glycoprotein inhibitors
- Participation in other Clinical research studies within one month of screening
- Subjects that the Investigator feels are inappropriate for the study
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United Kingdom7 sites
Leeds
Leeds
Liverpool
Liverpool
London
London
Manchester
Manchester
Newcastle Upon Tyne
Newcastle upon Tyne
Oxford
Oxford
Wigan
Wigan
United States5 sites
Butte
Butte, Montana, 59701
Idaho
Idaho Falls, Idaho, 83404
Laguna Hills
Laguna Hills, California, 92653
New Jersey
Somers Point, New Jersey, 08244
Ventura
Ventura, California, 93003
About this study
Official title: A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)
The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
- Conditions
- Clostridium Difficile Infection
- Being tested
- Ridinilazole, Fidaxomicin
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RidinilazoleDrug
Also called SMT19969
FidaxomicinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ridinilazole (SMT19969) | Experimental | 200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days Receives: Drug: Ridinilazole |
| Fidaxomicin | Active comparator | 200 mg tablet of Fidaxomicin twice a day for 10 days Receives: Drug: Fidaxomicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability
Measured: 30 days post End of Therapy
Secondary outcomes (4)
To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
Measured: 12 days
To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques
Measured: 40 days
Measure clinical cure rates at the Test of Cure (TOC) visit
Investigator assessed clinical response at the TOC visit (on day 12) with clinical cure defined as the resolution of diarrhoea (≤ 3 Unformed Bowel Movements (UBMs) per day) while on treatment that is maintained until the TOC visit.
Measured: 12 days
Measure sustained clinical response (SCR) rates
SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startDec 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summit Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Summit Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784002
- Sponsor's protocol ID
- SMT19969/C003
- Status last verified
- Oct 2017
- First submitted
- 16 May 2016
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)
- ClinicalTrials.gov ID
- NCT02784002
- Acronym / sponsor ID
- SMT19969/C003
- Conditions
- Clostridium Difficile Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Summit TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 26 May 2016 (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 purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ridinilazole (SMT19969) | Experimental | Drug: Ridinilazole200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days |
| Fidaxomicin | Active comparator | Drug: Fidaxomicin200 mg tablet of Fidaxomicin twice a day 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 (4 listed)
- Informed Consent
- Clinical diagnosis of CDI plus laboratory diagnostic test
- No more than 30 hours antimicrobial treatment for current CDI episode
- Female subjects of childbearing potential must use adequate contraception
Key exclusion criteria (7 listed)
- Life-threatening or fulminant CDI
- Subjects with 2 or more episodes of CDI in the previous year
- Females who are pregnant or breastfeeding
- History of inflammatory bowel disease
- Co-administration of potent P-glycoprotein inhibitors
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 |
|---|---|---|
| RidinilazoleAlso: SMT19969 | Drug | Ridinilazole (SMT19969) |
| Fidaxomicin | Drug | Fidaxomicin |
Primary outcome
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability
Time frame: 30 days post End of Therapy
4 secondary outcomes
To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
Time frame: 12 days
To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques
Time frame: 40 days
Measure clinical cure rates at the Test of Cure (TOC) visit
Time frame: 12 days
Measure sustained clinical response (SCR) rates
Time frame: 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Clostridium Difficile Infection
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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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
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
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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.
Medical Director study director
Summit Therapeutics
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ridinilazole and Fidaxomicin in people with Clostridium Difficile Infection, run by Summit Therapeutics at 16 sites in 3 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 12 Oct 2017. 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 United Kingdom, United States, Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability (time frame: 30 days post End of Therapy). 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 12 Oct 2017.