Clostridium Difficile InfectionPhase 2NCT02092935
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
A Phase 2 study testing SMT19969 and Vancomycin in people with Clostridium Difficile Infection, run by Summit Therapeutics at 26 sites in 2 countries.
Trial summary
The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- SMT19969 and Vancomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Apr 2014to Oct 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Clinical diagnosis of CDAD plus laboratory diagnostic test
- No more than 24 hrs antimicrobial treatment for current CDAD episode
- No more than 3 episodes of CDAD in prior 12 months
- No previous episode of CDAD within 30 days of study enrollment
- Female subjects of childbearing potential must use adequate contraception
Who cannot join
- Life-threatening or fulminant colitis
- Concurrent use of antibiotics or any other treatments for CDAD
- History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- Participation in other Clinical research studies within one month of screening
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States24 sites
Study site
Akron, Ohio
Study site
Baltimore, Maryland
Study site
Billings, Montana
Study site
Boston, Massachusetts
Study site
Butte, Montana
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbus, Ohio
Study site
Detroit, Michigan
Study site
Duluth, Minnesota
Study site
Idaho Falls, Idaho
Study site
Laguna Hills, California
Study site
Lima, Ohio
Study site
Long Beach, California
Study site
Minneapolis, Minnesota
Study site
Mobile, Alabama
Study site
Rapid City, South Dakota
Study site
Rochester, New York
Study site
Seattle, Washington
Study site
Sommers Point, New Jersey
Study site
Sylmar, California
Study site
Topeka, Kansas
Study site
Tupelo, Mississippi
Study site
Ventura, California
About this study
Official title: A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).
- Conditions
- Clostridium Difficile Infection
- Being tested
- SMT19969, Vancomycin
- Keywords
- CDAD, Clostridium Difficile
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMT19969Drug
VancomycinDrug
| Study group | Role | What they receive |
|---|---|---|
| SMT19969 | Experimental | 200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day Receives: Drug: SMT19969 |
| Vancomycin | Active comparator | 125 mg capsule four times a day for 10 days Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical outcome by assessment of sustained clinical response
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
Measured: 30 days post End of Therapy
Secondary outcomes (2)
Plasma and faecal concentrations of SMT19969
Using laboratory analysis
Measured: 40 Days
To assess the safety and tolerability of SMT19969 compared with vancomycin
Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study
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 posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summit Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Richard Vickers, PhD, Study director, Summit (Oxford) Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092935
- Sponsor's protocol ID
- SMT19969/C002
- Status last verified
- Oct 2016
- First submitted
- 18 Mar 2014
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Snydman DR, McDermott LA, Thorpe CM, Chang J, Wick J, Walk ST, Vickers RJ. Antimicrobial susceptibility and ribotypes of Clostridium difficile isolates from a Phase 2 clinical trial of ridinilazole (SMT19969) and vancomycin. J Antimicrob Chemother. 2018 Aug 1;73(8):2078-2084. doi: 10.1093/jac/dky135.
PubMed 29718329Vickers RJ, Tillotson GS, Nathan R, Hazan S, Pullman J, Lucasti C, Deck K, Yacyshyn B, Maliakkal B, Pesant Y, Tejura B, Roblin D, Gerding DN, Wilcox MH; CoDIFy study group. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Lancet Infect Dis. 2017 Jul;17(7):735-744. doi: 10.1016/S1473-3099(17)30235-9. Epub 2017 Apr 28.
PubMed 28461207
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
- ClinicalTrials.gov ID
- NCT02092935
- Acronym / sponsor ID
- SMT19969/C002
- Conditions
- Clostridium Difficile Infection
- Keywords
- CDAD, Clostridium Difficile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Summit TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Wellcome Trust
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Mar 2014 (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 a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).
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 |
|---|---|---|
| SMT19969 | Experimental | Drug: SMT19969200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day |
| Vancomycin | Active comparator | Drug: Vancomycin125 mg capsule four times a day for 10 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent
- Clinical diagnosis of CDAD plus laboratory diagnostic test
- No more than 24 hrs antimicrobial treatment for current CDAD episode
- No more than 3 episodes of CDAD in prior 12 months
- No previous episode of CDAD within 30 days of study enrollment
Key exclusion criteria (4 listed)
- Life-threatening or fulminant colitis
- Concurrent use of antibiotics or any other treatments for CDAD
- History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
- Participation in other Clinical research studies within one month of screening
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 |
|---|---|---|
| SMT19969 | Drug | SMT19969 |
| Vancomycin | Drug | Vancomycin |
Primary outcome
Evaluate the clinical outcome by assessment of sustained clinical response
Time frame: 30 days post End of Therapy
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
2 secondary outcomes
Plasma and faecal concentrations of SMT19969
Time frame: 40 Days
To assess the safety and tolerability of SMT19969 compared with vancomycin
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 20 Oct 2016.
- Derived from this study: PubMed 29718329Snydman DR, McDermott LA, Thorpe CM, Chang J, Wick J, Walk ST, Vickers RJ. Antimicrobial susceptibility and ribotypes of Clostridium difficile isolates from a Phase 2 clinical trial of ridinilazole (SMT19969) and vancomycin. J Antimicrob Chemother. 2018 Aug 1;73(8):2078-2084. doi: 10.1093/jac/dky135.
- Derived from this study: PubMed 28461207Vickers RJ, Tillotson GS, Nathan R, Hazan S, Pullman J, Lucasti C, Deck K, Yacyshyn B, Maliakkal B, Pesant Y, Tejura B, Roblin D, Gerding DN, Wilcox MH; CoDIFy study group. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Lancet Infect Dis. 2017 Jul;17(7):735-744. doi: 10.1016/S1473-3099(17)30235-9. Epub 2017 Apr 28.
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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.
Richard Vickers, PhD study director
Summit (Oxford) Limited
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMT19969 and Vancomycin in people with Clostridium Difficile Infection, run by Summit Therapeutics at 26 sites in 2 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 6 inclusion and 4 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 20 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 26 sites in United States, Canada. 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?
Evaluate the clinical outcome by assessment of sustained clinical response (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?
On the ClinicalTrials.gov record for NCT02092935, which also lists 2 linked publications.
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 20 Oct 2016.