Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Clostridioides Difficile Infection Clinical Trial

— Ri-CoDIFy 3  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04802837
• Other study ID #: SMT19969/C006
• Secondary ID: HHSO100201700014
• Status: Terminated
• Phase: Phase 3
• Start date: May 19, 2021
• Est. completion date: September 28, 2022

Study information

• Verified date: July 2023
• Source: Summit Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 28, 2022
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clostridioides Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Drug:
• Ridinilazole
Ridinilazole 200mg dosed BID for 10 days.
• Vancomycin
Vancomycin 125mg dosed QID for 10 days.

Locations

Country	Name	City	State
United States	Children's Center for Digestive Health	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
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	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	Children's Hospital of Michigan	Detroit	Michigan
United States	Snake River Research	Idaho Falls	Idaho
United States	Indiana University Health - Riley Hospital for Children	Indianapolis	Indiana
United States	University of California, Los Angeles (UCLA) David Geffen School of Medicine	Los Angeles	California
United States	Continental Clinical Research	Miami	Florida
United States	D&H National Research Centers	Miami	Florida
United States	Dynamic Medical Research LLC	Miami	Florida
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	Children's Hospital Orange County	Orange	California
United States	HMD Research	Orlando	Florida
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Summit Therapeutics	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

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