Ri-CoDIFy 3: Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

Sponsor

Summit Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04802837

Collaborator

Department of Health and Human Services (U.S. Fed)

Enrollment

Locations

Arms

30.4

Anticipated Duration (Months)

2.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Clostridioides Difficile Infection	Drug: Ridinilazole Drug: Vancomycin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 19, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ridinilazole Ridinilazole dosed BID and a comparator placebo dosed QID, to maintain blind, for 40 doses over 10 days.	Drug: Ridinilazole Ridinilazole 200mg dosed BID for 10 days.
Active Comparator: Vancomycin Vancomycin dosed QID and a Ridinilazole placebo dosed BID, to maintain blind, for 40 doses over 10 days.	Drug: Vancomycin Vancomycin 125mg dosed QID for 10 days.

Arm

Intervention/Treatment

Experimental: Ridinilazole

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

Drug: Ridinilazole

Ridinilazole 200mg dosed BID for 10 days.

Active Comparator: Vancomycin

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

Drug: Vancomycin

Vancomycin 125mg dosed QID for 10 days.

Outcome Measures

Primary Outcome Measures

Incidence and severity of treatment emergent adverse events [Day 1 through Study Completion, an average of 100 days]
Plasma concentration of ridinilazole [Day 1]
Plasma concentration of ridinilazole [Day 5]
Fecal concentration of ridinilazole [Day 1]
Fecal concentration of ridinilazole [Day 5]

Secondary Outcome Measures

Sustained clinical response (SCR) over 30 days post end of treatment (EOT) - defined as clinical cure at the assessment of cure (AOC) visit and no recurrence of CDI within 30 days post EOT [30 days post EOT]
Clinical cure at the assessment of cure (AOC) visit [Day 12]
Sustained clinical response over 60 days post EOT [60 days post EOT]
Sustained clinical response over 90 days post EOT [90 days post EOT]
SCR based on clinical response - defined as clinical response with no recurrence assessed through 30 days post-EOT [30 days post EOT]
Clinical response at the AOC visit [Day 12]

Other Outcome Measures

Medical resource utilization and health economics endpoints [Day 1 through Study Completion, an average of 100 days]
Data will include length of hospital stay, hospital admission and readmission rates and reasons for admission, subject location at admission and subject's discharge location, other location of healthcare access that didn't result in hospitalization i.e. urgent care facility, doctor visit, telemedicine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles (UCLA) David Geffen School of Medicine	Los Angeles	California	United States	90095
2	Children's Hospital Orange County	Orange	California	United States	92868
3	Continental Clinical Research	Miami	Florida	United States	33144
4	Dynamic Medical Research LLC	Miami	Florida	United States	33144
5	D&H National Research Centers	Miami	Florida	United States	33155
6	HMD Research	Orlando	Florida	United States	32819
7	Children's Center for Digestive Health	Atlanta	Georgia	United States	30342
8	Snake River Research	Idaho Falls	Idaho	United States	83404
9	Ann and Robert H Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611
10	University of Chicago - Comer Children's Hospital	Chicago	Illinois	United States	60637
11	Indiana University Health - Riley Hospital for Children	Indianapolis	Indiana	United States	46202
12	Boston Children's Hospital	Boston	Massachusetts	United States	02115
13	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
14	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
15	DiGiovanna Institute for Medical Education and Research	New York	New York	United States	11758
16	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
17	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
18	University Hospitals Cleveland Medical Center - Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106