Clostridioides Difficile InfectionPhase 3Ri-CoDIFy 3NCT04802837
Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
A Phase 3 study testing Ridinilazole and Vancomycin in people with Clostridioides Difficile Infection, run by Summit Therapeutics at 18 sites in United States.
Trial summary
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Clostridioides Difficile Infection
- What is being tested?
- Ridinilazole and Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 18 sitesUnited States
- Study dates
- 19 May 2021to 28 Sep 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is aged 12 to <18 years.
- Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.
Who cannot join
- Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization.
- Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months.
- Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization.
- Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.
- Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study.
- Is receiving treatment that generally is associated with severe diarrhea, intractable vomiting, severe nausea, or inability to swallow that cannot be managed with antiemetics or antidiarrheals and that limits the ability to take oral medications. Cancer treatment that does not comprise ability to take study medication or cause severe diarrhea is allowed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Children's Center for Digestive Health
Atlanta, Georgia, 30342
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
University of Chicago - Comer Children's Hospital
Chicago, Illinois, 60637
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Children's Hospital of Michigan
Detroit, Michigan, 48201
Snake River Research
Idaho Falls, Idaho, 83404
Indiana University Health - Riley Hospital for Children
Indianapolis, Indiana, 46202
University of California, Los Angeles (UCLA) David Geffen School of Medicine
Los Angeles, California, 90095
Continental Clinical Research
Miami, Florida, 33144
Dynamic Medical Research LLC
Miami, Florida, 33144
D&H National Research Centers
Miami, Florida, 33155
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
DiGiovanna Institute for Medical Education and Research
New York, New York, 11758
Children's Hospital Orange County
Orange, California, 92868
HMD Research
Orlando, Florida, 32819
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Official title: A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
- Conditions
- Clostridioides Difficile Infection
- Being tested
- Ridinilazole, Vancomycin
- Keywords
- Clostridioides difficile infection (CDI), ridinilazole, Adolescents, vancomycin, C. Diff, Clostridium difficile, Diarrhea, Infection, Pediatric
- Medical subject headings
- Clostridium Infections, Diarrhea, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RidinilazoleDrug
Ridinilazole 200mg dosed BID for 10 days.
VancomycinDrug
Vancomycin 125mg dosed QID for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Ridinilazole | Experimental | Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days. Receives: Drug: Ridinilazole |
| Vancomycin | Active comparator | Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days. Receives: Drug: Vancomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-emergant Adverse Events
Safety was assessed using CTCAE v4.
Measured: Until study completion (Day 100)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start19 May 2021
- Primary completion17 Sep 2021
- Study completion28 Sep 2022
Why it stopped: SMT19969-C006 study was terminated in alignment with corporate decision to pursue further development of drug candidate with a partner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridioides 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Summit Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Lori Styles, MD, Study director, Summit Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802837
- Sponsor's protocol ID
- SMT19969/C006
- Other IDs
- HHSO100201700014C
- Acronym
- Ri-CoDIFy 3
- Status last verified
- Jul 2023
- First submitted
- 9 Mar 2021
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Active Controlled Study to Evaluate the Safety and Tolerability of Ridinilazole Compared With Vancomycin and to Assess the Pharmacokinetics of Ridinilazole in Adolescent Subjects (Aged 12 to <18 Years) With Clostridioides Difficile Infection
- ClinicalTrials.gov ID
- NCT04802837
- Acronym / sponsor ID
- Ri-CoDIFy 3 / SMT19969/C006
- Conditions
- Clostridioides Difficile Infection
- Keywords
- Clostridioides difficile infection (CDI), ridinilazole, Adolescents, vancomycin, C. Diff, Clostridium difficile, Diarrhea, Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SMT19969-C006 study was terminated in alignment with corporate decision to pursue further development of drug candidate with a partner.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Summit TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Department of Health and Human Services
- Study start
- 19 May 2021 (actual)
- Primary completion
- 17 Sep 2021 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.
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 |
|---|---|---|
| Ridinilazole | Experimental | Drug: RidinilazoleRidinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days. |
| Vancomycin | Active comparator | Drug: VancomycinVancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Is aged 12 to <18 years.
- Has signs and symptoms of CDI including diarrhea such that in the Investigator's opinion CDI antimicrobial therapy is required, and the subject has tested positive for toxin A and/or B of C. difficile in the stool. Diarrhea is defined as ≥ 3 unformed bowel movements (UBMs) based on types 5, 6, 7 on the Bristol Stool Chart and diarrhea information is within 24 hours prior to randomization.
Key exclusion criteria (6 listed)
- Has had more than the equivalent of 48 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization.
- Has received ridinilazole or an investigational vaccine against C. difficile any time in the past, anti-toxic antibodies including bezlotoxumab within the past 6 months, or any other investigational medicinal product for treatment of CDI or fecal microbiota replacement therapy within the past 3 months.
- Has a clinically relevant positive stool test for pathogens other than C. difficile, within 48 hours of randomization.
- Has life-threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, toxic megacolon, or ileus.
- Has had major GI surgery (e.g. significant bowel resection or pancreatectomy but not including appendectomy or cholecystectomy) within past 3 months or has the presence of a colostomy or ileostomy or has the likely requirement of an ostomy during the study.
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 |
|---|---|---|
| RidinilazoleRidinilazole 200mg dosed BID for 10 days. | Drug | Ridinilazole |
| VancomycinVancomycin 125mg dosed QID for 10 days. | Drug | Vancomycin |
Primary outcome
Incidence and Severity of Treatment-emergant Adverse Events
Time frame: Until study completion (Day 100)
Safety was assessed using CTCAE v4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Lori Styles, MD study director
Summit Therapeutics
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ridinilazole and Vancomycin in people with Clostridioides Difficile Infection, run by Summit Therapeutics at 18 sites 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 2 inclusion and 6 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence and Severity of Treatment-emergant Adverse Events (time frame: Until study completion (Day 100)). 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 21 Aug 2023.