Comparison of ridinilazole versus vancomycin treatment for Clostridium difficile infectio
- Conditions
- Clostridium difficile infection (CDI)MedDRA version: 20.0 Level: PT Classification code 10054236 Term: Clostridium difficile infection System Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-001641-27-ES
- Lead Sponsor
- Summit (Oxford) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 680
Patients are eligible to be included in the study only if all the following criteria apply:
1. Patient must be at least 18 years of age, at the time of signing the informed consent.
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.
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.
5. Has provided documented signed informed consent and any authorizations required by local law (e.g. Protected Health Information [PHI]).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 340
Patients are excluded from the study if any of the following criteria apply:
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 treatment for active malignancy. Or active malignancy with ablative chemotherapy within the past 3 months or anticipated during the study.
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 6.5.1 for a list of potentially confounding medications).
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.
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method