Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Phase 3

Terminated

• Conditions: Clostridioides Difficile Infection
• Interventions: Drug: Ridinilazole; Drug: Vancomycin

• Registration Number: NCT04802837
• Lead Sponsor: Summit Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-09
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Study Start: 2021-05-19
• Primary Completion: 2021-09-17
• Study Completion: 2022-09-28
• Results First Submitted: 2023-01-27
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-28
• Last Update Submitted: 2023-07-28
• Results First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ridinilazole	Ridinilazole	Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.
Vancomycin	Vancomycin	Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.

Primary Outcome Measures

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

Trial Locations

Locations (18)

Stony Brook University Medical Center; 🇺🇸 Stony Brook, New York, United States

Continental Clinical Research; 🇺🇸 Miami, Florida, United States

Indiana University Health - Riley Hospital for Children; 🇺🇸 Indianapolis, Indiana, United States

Children's Hospital Orange County; 🇺🇸 Orange, California, United States

University of California, Los Angeles (UCLA) David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States

D&H National Research Centers; 🇺🇸 Miami, Florida, United States

Children's Center for Digestive Health; 🇺🇸 Atlanta, Georgia, United States

University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital; 🇺🇸 Cleveland, Ohio, United States

Snake River Research; 🇺🇸 Idaho Falls, Idaho, United States

HMD Research; 🇺🇸 Orlando, Florida, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Dynamic Medical Research LLC; 🇺🇸 Miami, Florida, 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

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States

DiGiovanna Institute for Medical Education and Research; 🇺🇸 New York, New York, United States

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States