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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 : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Summit Therapeutics

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.


Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: ridinilazole Drug: vancomycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
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
Official Title: 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)
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ridinilazole Drug: ridinilazole
ridinilazole (200 mg bid)

Active Comparator: vancomycin Drug: vancomycin
vancomycin (125 mg qid)




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Clinical cure at Assessment of Cure (AOC) visit [ Time Frame: Day 12 ]
  2. Sustained clinical response over 60 days [ Time Frame: Day 70 ]
  3. Sustained clinical response over 90 days [ Time Frame: Day 100 ]
  4. Incidence of treatment related adverse events as per CTCAE v4.0 [ Time Frame: From Day 1 to Day 100 (end of study) ]
  5. Peak plasma concentration of ridinilazole [ Time Frame: 2 and 4 hours post Day 1 dose. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03595553


Contacts
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Contact: Lauren Kuhn +1 617 225 4464 lauren.kuhn@summitplc.com
Contact: Winnie Barlow 01235 443939 winnie.barlow@summitplc.com

Locations
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United States, Montana
Mercury Street Medical Group PLLC Recruiting
Butte, Montana, United States, 59701
Contact: Justin DeShazo    406-723-1375    Justin.Deshazo@mercurystmed.com   
Sponsors and Collaborators
Summit Therapeutics
Investigators
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Study Director: Richard Vickers, PhD Summit (Oxford) Limited

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Summit Therapeutics
ClinicalTrials.gov Identifier: NCT03595553     History of Changes
Other Study ID Numbers: SMT19969/C004
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
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

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents