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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

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

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Locations
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United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
United States, California
Facey Medical Foundation Recruiting
Mission Hills, California, United States, 91345
Paradigm Clinical Research Centers, Inc Recruiting
Redding, California, United States, 96601
United States, Florida
Alliance Medical Research LLC Recruiting
Lighthouse Point, Florida, United States, 33064
San Marcus Research Recruiting
Miami Lakes, Florida, United States, 33014
Oceane7 Medical Research Center Inc. Recruiting
Miami, Florida, United States, 33144
Bioclinical Research Alliance Recruiting
Miami, Florida, United States, 33155
Gasteroenterology Group of Naples Recruiting
Naples, Florida, United States, 31402
HeuerMD Research Inc Recruiting
Orlando, Florida, United States, 32819
Pines Care Research Center Inc. Recruiting
Pembroke Pines, Florida, United States, 33026
Professional Health Care of Pinellas Recruiting
Saint Petersburg, Florida, United States, 33713
Bardmoor Gastroenterology Recruiting
Seminole, Florida, United States, 33777
Triple O Research Institute PA Recruiting
West Palm Beach, Florida, United States, 33407
Florida Medical Clinic P.A. Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Infectious Disease Specialists of Atlanta Recruiting
Decatur, Georgia, United States, 30333
Nexclin Medicine, LLC Recruiting
Roswell, Georgia, United States, 30076
United States, Illinois
University Of Illinois Medical Center Recruiting
Chicago, Illinois, United States, 606012
Springfield Clinic LLP Recruiting
Springfield, Illinois, United States, 62703
United States, Kansas
WestGlen Gastrointestinal Consultants P.A. an Elligo Health Research Site Recruiting
Shawnee Mission, Kansas, United States, 66217
United States, Louisiana
Lafayette General Medical Center Recruiting
Lafayette, Louisiana, United States, 70503
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
United States, Michigan
Aa Mrc Llc Recruiting
Flint, Michigan, United States, 48504-4730
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073-6712
United States, Montana
Mercury Street Medical Group PLLC Recruiting
Butte, Montana, United States, 59701
United States, Nevada
AB Clinical Trials Recruiting
Las Vegas, Nevada, United States, 89119
United States, New Jersey
South Jersey Infectious Disease Recruiting
Somers Point, New Jersey, United States, 08244
United States, New York
New York Presbyterian Hospital Weill Cornell Recruiting
New York, New York, United States, 10021
United States, North Carolina
PMG Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Dakota
Rapid City Regional Health Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Chattanooga Research and Medicine CHARM Recruiting
Chattanooga, Tennessee, United States, 37404-3230
Advanced Gastroenterology Recruiting
Union City, Tennessee, United States, 38261
United States, Texas
DM Clinical Research (Conroe Regional Hospital) Recruiting
Conroe, Texas, United States, 77304
FMC Science Recruiting
Lampasas, Texas, United States, 76550
Pearland Physicians Recruiting
Pearland, Texas, United States, 77581
United States, Utah
Val R. Hansen, MD Recruiting
Bountiful, Utah, United States, 84010
United States, Virginia
Infectious Diseases Associates of Central VA Recruiting
Lynchburg, Virginia, United States, 24501
Argentina
Instituto Medico ALAS Recruiting
Salta, Argentina, CP4400
Australia, New South Wales
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Sunshine Coast University Hospital Recruiting
Birtinya, Queensland, Australia, 4575
The Townsville Hospital Recruiting
Douglas, Queensland, Australia, 4814
Mater Misericordiae Recruiting
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Lyell McEwin Hospital Recruiting
Adelaide, South Australia, Australia, 5112
Australia, Victoria
Monash Medical Center Recruiting
Clayton, Victoria, Australia, 3168
Barwon Health - University Hospital Geelong Recruiting
Geelong, Victoria, Australia, 3220
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
New Zealand
Waitemata District Health Board WDHB North Shore Hospital Recruiting
Takapuna, Auckland, New Zealand, 0740
Taranaki District Health Board TDHB - Taranaki Base Hospital Recruiting
New Plymouth, Taranki, New Zealand, 4310
Waikato District Health Board Waikato Hospital Recruiting
Hamilton, Waikato, New Zealand, 3240
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: August 13, 2019
Last Verified: August 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