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Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection (Ri-CoDIFy 1)

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ClinicalTrials.gov Identifier: NCT03595553
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : August 13, 2019
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 August 13, 2019
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 Complete list of historical versions of study NCT03595553 on ClinicalTrials.gov Archive Site
Current 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) ]
  • Peak plasma concentration of ridinilazole [ Time Frame: 2 and 4 hours post Day 1 dose. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of 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) 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 same number and appearance of IP in both arms.
Primary Purpose: Treatment
Condition  ICMJE Clostridium Difficile Infection
Intervention  ICMJE
  • Drug: ridinilazole
    ridinilazole (200 mg bid)
  • Drug: vancomycin
    vancomycin (125 mg 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:

  1. At least 18 years of age, at the time of signing the informed consent.
  2. 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. The presence of either toxin A and/or B of C. difficile in the stool determined by a positive free toxin test, produced within 72 hours prior to randomization.
  4. Male or Female

    • Male must agree to use contraception as detailed in the protocol during the treatment period and for at least 5 days after study treatment and refrain from donating sperm during this period.
    • Female patient is eligible to participate if she is not pregnant, not breastfeeding, and either:

    Not a woman of childbearing potential (WOCBP). A WOCBP who agrees to follow the contraceptive guidance per protocol during the treatment period and for at least 5 days after study treatment.

  5. Documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]).

Exclusion Criteria:

  1. More than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months.
  2. A history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  3. Positive diagnostic test for other gastro intestinal (GI) pathogens within 2 weeks of randomization.
  4. Major gastrointestinal (GI) surgery (e.g. significant bowel resection) within 3 months of randomization (except appendectomy). Presence of a colostomy or ileostomy or likely requirement of an ostomy during the study.
  5. Life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon.
  6. Current history of significantly compromised immune system e.g.:

    1. HIV positive with a CD4<200 cells/mm3 within 6 months of randomization.
    2. Severe neutropenia with neutrophil count < 500 cells/mL.
    3. Concurrent immunosuppressive therapy for recent (within previous 6 months) or anticipated solid organ transplant or bone marrow transplant.
    4. Concurrent chemotherapy, radiotherapy or biologic for active malignancy. Or active malignancy with ablative chemotherapy within the past 3 months or anticipated during the study.
  7. More than one day (24 hours) of dosing of antimicrobial treatment active against CDI for the current episode of CDI prior to randomization.
  8. Prior or current use of anti-toxin antibodies including bezlotoxumab.
  9. Unable to discontinue products used to affect bowel movement or disease progression.
  10. Involved in a clinical trial and received an IMP for indications other than CDI within 1 month or five half-lives (whichever is longer) or within 3 months if the IMP was for CDI.
  11. Received an investigational vaccine against C.difficile.
  12. Patients that the Investigator feels are inappropriate for the study for any other reason e.g. have any conditions that would make the patient unsuitable for inclusion, patients not likely to complete the study for whatever reason, known hypersensitivity or intolerance to study IMPs, patients unwilling or unable to comply with protocol requirements
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: Lauren Kuhn +1 617 225 4464 lauren.kuhn@summitplc.com
Contact: Winnie Barlow 01235 443939 winnie.barlow@summitplc.com
Listed Location Countries  ICMJE Argentina,   Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03595553
Other Study ID Numbers  ICMJE SMT19969/C004
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: Richard Vickers, PhD Summit (Oxford) Limited
PRS Account Summit Therapeutics
Verification Date August 2019

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