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To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 2)

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ClinicalTrials.gov Identifier: NCT03595566
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Summit Therapeutics

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE July 23, 2018
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE January 28, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
Sustained clinical response defined as clinical cure at the Assessment of Cure (AOC) visit and no recurrence of CDI within 30 days post end of treatment (EOT) [ Time Frame: Day 40 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2021)
  • Clinical cure at Assessment of Cure (AOC) visit [ Time Frame: Day 12 ]
  • Sustained clinical response over 60 days [ Time Frame: Day 70 ]
    defined as clinical cure at the AOC visit and no recurrence of CDI within 60 days post EOT
  • Sustained clinical response over 90 days [ Time Frame: Day 100 ]
    defined as clinical cure at the AOC visit and no recurrence of CDI within 90 days post EOT
  • Investigator assessment of clinical cure at the AOC visit [ Time Frame: Day 12 ]
  • Investigator assessment of sustained clinical response at 30, 60- and 90-days post EOT [ Time Frame: Days 40, 70 and 100 ]
  • Relative abundance and diversity of the microbiome and bile salt composition in fecal samples at the end of treatment [ Time Frame: Day 1 to Day 40 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • Clinical cure at Assessment of Cure (AOC) visit [ Time Frame: Day 12 ]
  • Sustained clinical response over 60 days [ Time Frame: Day 70 ]
  • Sustained clinical response over 90 days [ Time Frame: Day 100 ]
  • Incidence of treatment related adverse events as per CTCAE v4.0 [ Time Frame: From Day 1 to Day 100 (end of study) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Compare Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
Official Title  ICMJE A Phase 3, Randomized, Double-blind, Active Controlled Study to Compare the Efficacy and Safety of Ridinilazole (200 mg, Bid) for 10 Days With Vancomycin (125 mg, Qid) for 10 Days in the Treatment of Clostridium Difficile Infection (CDI)
Brief Summary

Summit is developing ridinilazole as a novel antimicrobial for Clostridium difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of achieving comparable cure rates to standard of care, but reducing rates of recurrent disease.

A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted.

The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
In both arms patients receive the same number of doses per day. Placebo tablets are included to maintain the same number and appearance of IP in both arms.
Primary Purpose: Treatment
Condition  ICMJE Clostridioides Difficile Infection
Intervention  ICMJE
  • Drug: ridinilazole
    ridinilazole 200mg bid
  • Drug: vancomycin
    vancomycin 125mg qid
Study Arms  ICMJE
  • Experimental: ridinilazole
    Intervention: Drug: ridinilazole
  • Active Comparator: vancomycin
    Intervention: Drug: vancomycin
Publications * Carlson TJ, Endres BT, Bassères E, Gonzales-Luna AJ, Garey KW. Ridinilazole for the treatment of Clostridioides difficile infection. Expert Opin Investig Drugs. 2019 Apr;28(4):303-310. doi: 10.1080/13543784.2019.1582640. Epub 2019 Feb 26. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 11, 2018)
680
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Patients are eligible to be included in the study only if all the following criteria apply:

  1. Patient must be at least 18 years of age, at the time of signing the informed consent.
  2. Have signs and symptoms of CDI including diarrhea such that in the Investigator's opinion, CDI antimicrobial therapy is required. Diarrhea is defined as a change in bowel habits, with ≥3 unformed bowel movements (UBMs) (5, 6 or 7 on the Bristol Stool Chart) in the 24 h prior to randomization.
  3. Have the presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test (using a Sponsor agreed test). The stool sample must be current (produced within 72 hours prior to randomization).
  4. Male or Female

    Male patients:

    • A male patient must agree to use contraception as detailed in Section 10.4 of this protocol during the treatment period and for at least 30 days after the last dose of study treatment and refrain from donating sperm during this period.

    Female patients:

    • A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of study treatment.

  5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]). If unable to read, understand and sign the informed consent form a legally authorized representative (LAR) may provide consent on the patient's behalf if permitted by the Institutional Review Board (IRB)/Ethics Committee (EC).

Exclusion Criteria

Patients are excluded from the study if any of the following criteria apply:

  1. Have had more than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months prior to randomization.
  2. Have a history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  3. Have had a positive diagnostic test for other GI pathogens, considered to be clinically relevant, within 2 weeks of randomization.
  4. Have had major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (this does not include appendectomy). The presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
  5. Have life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
  6. History of bone marrow or hematopoietic stem cell transplant at any time or a known current history of a severely compromised/suppressed immune system that, in the opinion of the Investigator, would make the patient unsuitable for the study.
  7. Have had more than the equivalent of 24 hours of dosing of antimicrobial treatment active against the current episode of CDI prior to randomization. (i.e. more than four doses of oral vancomycin, two doses of fidaxomicin or three doses of metronidazole).
  8. Prior or current use of anti-toxin antibodies including bezlotoxumab within the past 6 months prior to randomization.
  9. Are unable to discontinue products used affecting disease progression at randomization.
  10. Has been involved in a clinical trial and received an investigational medicinal product for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the investigational medical product was for CDI.
  11. Have received an investigational vaccine against C. difficile.
  12. Patients that the Investigator feels are inappropriate for the study this would include those;

    1. with any other condition that, in the Investigator's judgment, would make the patient unsuitable for inclusion in the study.
    2. who, in the opinion of the Investigator, are not likely to complete the study for whatever reason, e.g. short life expectancy.
    3. with known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or their excipients
    4. who are unwilling or unable to comply with protocol requirements, e.g. complete the full course of study treatment per schedule, attend study visits, report diarrhea/suspected recurrence, provide stool samples, ingest capsules/tablets or blood draws.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Alvarado +1 617 401 3341 mary.alvarado@summitplc.com
Listed Location Countries  ICMJE Belarus,   Belgium,   Canada,   Chile,   Czechia,   Estonia,   France,   Georgia,   Germany,   Israel,   Latvia,   Lithuania,   Mexico,   Peru,   Romania,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03595566
Other Study ID Numbers  ICMJE SMT19969/C005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Summit Therapeutics
Study Sponsor  ICMJE Summit Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jos Houbiers, MD, PhD Summit Therapeutics
PRS Account Summit Therapeutics
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP