Clinical trial NCT04802837: Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Clostridioides Difficile Infection
Keywords: Clostridioides difficile infection (CDI)
ridinilazole
Adolescents
vancomycin
C. Diff
Clostridium difficile
Diarrhea
Infection
Pediatric
Lead sponsor: Summit Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2021-03-17
Enrollment: 2
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and Severity of Treatment-emergant Adverse Events
timeFrame: Until study completion (Day 100)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA) David Geffen School of Medicine
state: California
city: Orange
country: United States
facility: Children's Hospital Orange County
state: California
city: Miami
country: United States
facility: Continental Clinical Research
state: Florida
city: Miami
country: United States
facility: Dynamic Medical Research LLC
state: Florida
city: Miami
country: United States
facility: D&H National Research Centers
state: Florida
city: Orlando
country: United States
facility: HMD Research
state: Florida
city: Atlanta
country: United States
facility: Children's Center for Digestive Health
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research
state: Idaho
city: Chicago
country: United States
facility: Ann and Robert H Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago - Comer Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health - Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: DiGiovanna Institute for Medical Education and Research
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital
state: Ohio
Study officials:
affiliation: Summit Therapeutics
name: Lori Styles, MD
role: STUDY_DIRECTOR
References: