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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04802837
Recruitment Status : Recruiting
First Posted : March 17, 2021
Last Update Posted : May 16, 2022
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Summit Therapeutics

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Incidence and severity of treatment emergent adverse events [ Time Frame: Day 1 through Study Completion, an average of 100 days ]
  2. Plasma concentration of ridinilazole [ Time Frame: Day 1 ]
  3. Plasma concentration of ridinilazole [ Time Frame: Day 5 ]
  4. Fecal concentration of ridinilazole [ Time Frame: Day 1 ]
  5. Fecal concentration of ridinilazole [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 30 days post EOT ]
  2. Clinical cure at the assessment of cure (AOC) visit [ Time Frame: Day 12 ]
  3. Sustained clinical response over 60 days post EOT [ Time Frame: 60 days post EOT ]
  4. Sustained clinical response over 90 days post EOT [ Time Frame: 90 days post EOT ]
  5. SCR based on clinical response - defined as clinical response with no recurrence assessed through 30 days post-EOT [ Time Frame: 30 days post EOT ]
  6. Clinical response at the AOC visit [ Time Frame: Day 12 ]

Other Outcome Measures:
  1. Medical resource utilization and health economics endpoints [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04802837


Contacts
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Contact: Sr. Director, Medical Information +1 833 256 0522 medicalinformation@summitplc.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Summit Therapeutics
Department of Health and Human Services
Investigators
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Study Director: Lori Styles, MD Summit Therapeutics
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Responsible Party: Summit Therapeutics
ClinicalTrials.gov Identifier: NCT04802837    
Other Study ID Numbers: SMT19969/C006
HHSO100201700014C ( Other Identifier: Department of Health and Human Services )
First Posted: March 17, 2021    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Summit Therapeutics:
Clostridioides difficile infection (CDI)
ridinilazole
Adolescents
vancomycin
C. Diff
Clostridium difficile
Diarrhea
Infection
Pediatric
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Clostridium Infections
Disease Attributes
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents