Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Stopped early · Phase 3

Conditions studied: Clostridioides Difficile Infection

In brief

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

Key facts

Study ID

NCT04802837

Run by

Summit Therapeutics

People needed

2

Starts

2021-05-19

Expected to finish

2022-09-28

Last updated by the study team

2023-08-21

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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