Safety, Tolerability and the Pharmacokinetics of Ridinilazole in Adolescent Subjects

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

Official Title
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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

Conditions
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Clostridioides Difficile Infection

Intervention / Treatment
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* Drug: Ridinilazole
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and Severity of Treatment-emergant Adverse Events | Safety was assessed using CTCAE v4. | Until study completion (Day 100) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clostridioides difficile infection (CDI), ridinilazole, Adolescents, vancomycin, C. Diff, Clostridium difficile, Diarrhea, Infection, Pediatric