TerminatedNCT04802837Ri-CoDIFy 3Updated Aug 21, 2023Results posted

Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

A Phase 3 interventional study of Ridinilazole and Vancomycin in Clostridioides Difficile Infection, sponsored by Summit Therapeutics. Terminated at 18 sites in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Summit Therapeutics · Phase 3, Interventional, and Treatment

Why this study was terminated

SMT19969-C006 study was terminated in alignment with corporate decision to pursue further development of drug candidate with a partner.

Phase: Phase 3
Study type: Interventional
Enrollment: 2
Allocation: Randomized
Ages: 12 Years to 17 Years
Sex: All

Study summary

Study to evaluate the safety of ridinilazole in adolescent subjects and how ridinilazole is metabolized.

Conditions studied

Clostridioides Difficile Infection

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Keywords

Clostridioides difficile infection (CDI)
ridinilazole
Adolescents
vancomycin
C. Diff
Clostridium difficile
Diarrhea
Infection
Pediatric

In context

Clostridium Infections

251 studies on the registry are indexed under Clostridium Infections; 51 are open to participants now.

This study's enrollment of 2 is below the median of 64 across 185 interventional studies indexed under Clostridium Infections.

Browse Clostridium Infections studies →

Lead sponsor

Summit Therapeutics is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2 participants (actual)

Study arms

Experimental
Ridinilazole
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Drug: Ridinilazole
Active comparator
Vancomycin
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Drug: Vancomycin

Interventions

DrugRidinilazole
Ridinilazole 200mg dosed BID for 10 days.
DrugVancomycin
Vancomycin 125mg dosed QID for 10 days.

What researchers measure

Primary outcomes

Incidence and Severity of Treatment-emergant Adverse Events
Safety was assessed using CTCAE v4.
Time frame: Until study completion (Day 100)

Results

Posted Aug 21, 2023

Participant flow

Participant flow — Overall Study
Milestone	Ridinilazole	Vancomycin
Started	1	1
Completed	1	1
Not completed	0	0

Outcome measures

PrimaryIncidence and Severity of Treatment-emergant Adverse Events

Safety was assessed using CTCAE v4.

Time frame:: Until study completion (Day 100)
Reported as:: Count of participants · Participants

Incidence and Severity of Treatment-emergant Adverse Events
Participants	Ridinilazole	Vancomycin
Incidence and Severity of Treatment-emergant Adverse Events	0	0

Adverse events

Collected over Until study completion (Day 100). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ridinilazole	0/1 (0%)	0/1 (0%)	0/1 (0%)
Vancomycin	0/1 (0%)	0/1 (0%)	0/1 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Ridinilazole	Vancomycin	Total
<=18 years	1	1	2
Between 18 and 65 years	0	0	0
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Ridinilazole	Vancomycin	Total
Female	0	0	0
Male	1	1	2

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ridinilazole	Vancomycin	Total
Hispanic or Latino	1	1	2
Not Hispanic or Latino	0	0	0
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Ridinilazole	Vancomycin	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	1	1
White	1	0	1
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Study locations

18 sites

University of California, Los Angeles (UCLA) David Geffen School of Medicine
Los Angeles, California 90095, United States
Children's Hospital Orange County
Orange, California 92868, United States
Continental Clinical Research
Miami, Florida 33144, United States
Dynamic Medical Research LLC
Miami, Florida 33144, United States
D&H National Research Centers
Miami, Florida 33155, United States
HMD Research
Orlando, Florida 32819, United States
Children's Center for Digestive Health
Atlanta, Georgia 30342, United States
Snake River Research
Idaho Falls, Idaho 83404, United States
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois 60611, United States
University of Chicago - Comer Children's Hospital
Chicago, Illinois 60637, United States
Indiana University Health - Riley Hospital for Children
Indianapolis, Indiana 46202, United States
Boston Children's Hospital
Boston, Massachusetts 02115, United States
Children's Hospital of Michigan
Detroit, Michigan 48201, United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029, United States
DiGiovanna Institute for Medical Education and Research
New York, New York 11758, United States
Stony Brook University Medical Center
Stony Brook, New York 11794, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229, United States
University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital
Cleveland, Ohio 44106, United States

References and documents

Study documents

Study protocol ↗ · Nov 12, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from May 2021 to primary completion in Sep 2021, 3 months.

Results were first posted in Aug 2023, 1 year 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 9, 2021
First posted: Mar 17, 2021
StartActual: May 19, 2021
Primary completionActual: Sep 17, 2021
CompletionActual: Sep 28, 2022
Results first posted: Aug 21, 2023
Last update: Aug 21, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04802837
Lead sponsor: Summit Therapeutics
Collaborators: Department of Health and Human Services
Responsible party: Sponsor
First posted: Mar 17, 2021
Start date: May 19, 2021
Primary completion: Sep 17, 2021
Completion: Sep 28, 2022
Results posted: Aug 21, 2023
Last update: Aug 21, 2023

Study contacts

Lori Styles, MD

study director · Summit Therapeutics

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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