COMPARISON OF RIDINILAZOLE VERSUS VANCOMYCIN TREATMENT FORCLOSTRIDIUM DIFFICILE INFECTIO
- Conditions
- -A047 Enterocolitis due to Clostridium difficileEnterocolitis due to Clostridium difficileA047
- Registration Number
- PER-005-19
- Lead Sponsor
- Summit (Oxford) Limited,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria Patients are eligible to be included in the study only if all
the following criteria apply: Age 1. Patient must be at least 18 years of age,
at the time of signing the informed consent. Type of Patient and Disease
Characteristics 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 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 have been produced within 72 hours prior to randomization. Sex 4.
Male or Female Male patients: • A male patient must agree to use
contraception as detailed in Appendix 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
(see Appendix 4), not breastfeeding, and at least one of the following
conditions applies: i. Not a woman of childbearing potential (WOCBP) as
defined in Appendix 4 OR ii. A WOCBP who agrees to follow the
contraceptive guidance in Appendix 4 during the treatment period and for at
least 30 days after the last dose of study treatment. Informed Consent 5.
Has provided documented signed informed consent and any authorizations
required by local law (e.g. Protected Health Information [PHI]).
Exclusion Criteria Patients are excluded from the study if any of the
following criteria apply: Medical Conditions 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 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. Have a known current history of significantly
compromised immune system e.g. a. HIV positive with a CD4<200
cells/mm3 within 6 months of randomization. b. Severe neutropenia with
neutrophil count < 500 cells/mL. c. Are on concurrent immunosuppressive
therapy for recent (within previous 6 months) or anticipated solid organ
transplant or bone marrow transplant. d. Are on a concurrent
chemotherapy, radiotherapy or biologic for active malignancy. Or active
malignancy with ablative chemotherapy within the past 3 months or
anticipated during the study. Prior/Concomitant Therapy 7. Have had more
than 24 hours of dosing, or equivalent (i.e. four doses of oral vancomycin,
two doses of fidaxomicin or three doses of metronidazole) of antimicrobial
treatment active against the current episode of CDI prior to randomization.
8. Prior or current use of anti-toxin antibodies including bezlotoxumab 9.
Are unable to discontinue products used to affect bowel movement or
disease progression (see Section 6.5.1 for a list of potentially confounding
medications). Prior/Concurrent Clinical Study Experience 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. Other
Exclusions 12. Patients that the Investigator feels are inappropriate for the
study this would include those; a. with any other condition that, in the
Investigator´s judgment, would make the patient unsuitable for inclusion in
the study. b. who, in the opinion of the Investigator, are not likely to
complete the study for whatever reason. E.g. short life expectancy. c. with
known hypersensitivity or intolerance to ridinilazole, vancomycin, and/or
their excipients d. who are unwilling or unable to comply with protocol
requirements, e.g. complete the full course of study treatment per schedule,
attend study visits, complete an electronic diary (or have a caregiver able to
complete this on the patient’s behalf), provide stool samples, ingest
capsules, blood draws.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method