Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

NCT04802837 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: SMT19969/C006HHSO100201700014C
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Clostridioides Difficile Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-emergant Adverse Events

  Safety was assessed using CTCAE v4.

  Until study completion (Day 100)

Study Arms (2)

Ridinilazole

EXPERIMENTAL

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

Drug: Ridinilazole

Vancomycin

ACTIVE COMPARATOR

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

Drug: Vancomycin

Interventions

Ridinilazole DRUG

Ridinilazole 200mg dosed BID for 10 days.

Ridinilazole

Vancomycin DRUG

Vancomycin 125mg dosed QID for 10 days.

Vancomycin

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Summit Therapeutics: lead
• Department of Health and Human Services: collaborator

Study Sites (18)

University of California, Los Angeles (UCLA) David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Children's Hospital Orange County

Orange, California, 92868, United States

Location

Continental Clinical Research

Miami, Florida, 33144, United States

Location

Dynamic Medical Research LLC

Miami, Florida, 33144, United States

Location

D&H National Research Centers

Miami, Florida, 33155, United States

Location

HMD Research

Orlando, Florida, 32819, United States

Location

Children's Center for Digestive Health

Atlanta, Georgia, 30342, United States

Location

Snake River Research

Idaho Falls, Idaho, 83404, United States

Location

Ann and Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

University of Chicago - Comer Children's Hospital

Chicago, Illinois, 60637, United States

Location

Indiana University Health - Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

DiGiovanna Institute for Medical Education and Research

New York, New York, 11758, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Clostridium Infections; Diarrhea; Infections

Interventions

ridinilazole; Vancomycin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Katie Tran
• Organization: Summit Therapeutics

Katie.Tran@Summitplc.com

4086776503

Study Officials

• Lori Styles, MD

  Summit Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 17, 2021
• Study Start: May 19, 2021
• Primary Completion: September 17, 2021
• Study Completion: September 28, 2022
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)