Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

  • STATUS
    Recruiting
  • End date
    Sep 8, 2021
  • participants needed
    680
  • sponsor
    Summit Therapeutics
Updated on 8 July 2020
Investigator
Lauren Kuhn
Primary Contact
The Townsville Hospital (0.0 mi away) Contact
+223 other location
antibiotic therapy
antibiotics
diarrhea
vancomycin
clostridium difficile
ridinilazole

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.

Details
Treatment Vancomycin, ridinilazole
Clinical Study IdentifierNCT03595553
SponsorSummit Therapeutics
Last Modified on8 July 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Clostridium Difficile Infection?
At least 18 years of age, at the time of signing the informed consent
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
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
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
\. Documented signed informed consent and any authorizations required by
local law (e.g. Protected Health Information [PHI])

Exclusion Criteria

More than one prior episode of CDI in the previous 3 months or more than 3 episodes in the past 12 months
A history of chronic diarrheal disease including inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Positive diagnostic test for other gastro intestinal (GI) pathogens within 2 weeks of randomization
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
Life threatening or fulminant CDI with evidence of hypotension, septic shock, peritoneal signs or absence of bowel sounds, or toxic megacolon
Current history of significantly compromised immune system e.g
HIV positive with a CD4<200 cells/mm3 within 6 months of randomization
Severe neutropenia with neutrophil count < 500 cells/mL
Concurrent immunosuppressive therapy for recent (within previous 6 months) or anticipated solid organ transplant or bone marrow transplant
Concurrent chemotherapy, radiotherapy or biologic for active malignancy. Or active malignancy with ablative chemotherapy within the past 3 months or anticipated during the study
More than one day (24 hours) of dosing of antimicrobial treatment active against CDI for the current episode of CDI prior to randomization
Prior or current use of anti-toxin antibodies including bezlotoxumab
Unable to discontinue products used to affect bowel movement or disease progression
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
Received an investigational vaccine against C.difficile
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
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