Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
NCT ID: NCT04802837
Last Updated: 2023-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
2 participants
INTERVENTIONAL
2021-05-19
2022-09-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
NCT03595553
A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
NCT02784002
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
NCT04781387
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
NCT02092935
A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis
NCT01559545
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ridinilazole
Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Ridinilazole
Ridinilazole 200mg dosed BID for 10 days.
Vancomycin
Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.
Vancomycin
Vancomycin 125mg dosed QID for 10 days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ridinilazole
Ridinilazole 200mg dosed BID for 10 days.
Vancomycin
Vancomycin 125mg dosed QID for 10 days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
12 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Health and Human Services
FED
Summit Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lori Styles, MD
Role: STUDY_DIRECTOR
Summit Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, Los Angeles (UCLA) David Geffen School of Medicine
Los Angeles, California, United States
Children's Hospital Orange County
Orange, California, United States
Continental Clinical Research
Miami, Florida, United States
Dynamic Medical Research LLC
Miami, Florida, United States
D&H National Research Centers
Miami, Florida, United States
HMD Research
Orlando, Florida, United States
Children's Center for Digestive Health
Atlanta, Georgia, United States
Snake River Research
Idaho Falls, Idaho, United States
Ann and Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago - Comer Children's Hospital
Chicago, Illinois, United States
Indiana University Health - Riley Hospital for Children
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
DiGiovanna Institute for Medical Education and Research
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HHSO100201700014C
Identifier Type: OTHER
Identifier Source: secondary_id
SMT19969/C006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.