The study will look at how safe and well tolerated SMT19969 is compared to fidaxomcin when given orally for 10 days. It will also study if SMT19969 gets into the blood stream, what effect the body has on the drug, how the drug is removed from the body and how long it takes the body to remove it. It will assess the effect of SMT19969 and fidaxomicin on gut bacteria and compare the ability of SMT19969 and fidaxomicin to treat clostridium difficile infection (CDI) and reduce the recurrence of CDI.

Phase 1

• Conditions: Clostridium difficile infection; MedDRA version: 19.0Level: PTClassification code 10054236Term: Clostridium difficile infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-005483-25-CZ
• Lead Sponsor: Summit (Oxford) Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-12
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of screening.
1. Willingness to comply with all study activities and procedures and to provide signed, written informed consent prior to any study procedures. Where required and agreed by the subject a designated family member/next of kin/carer caregiver” may support an individual in their participation in the study. These individuals must be fully informed of the study requirements and the limits/requirements of their participation.
2. Male or female subjects who are in-patients or out-patients at time of consent, 18 years of age or older, and satisfy the diagnosis of CDI by clinical and laboratory criteria.
a. Diarrhoea defined as a change in bowel habits, with >3 unformed bowel movements (UBMs) or >200 mL unformed stool for subjects having rectal collection devices in the 24 hours prior to randomization;
b. Presence of either toxin A and/or B of C. difficile in the stool determined by any locally available FDA cleared test (US Only) for C. difficile toxin, including the Alere C.DIFF QUIK CHEK COMPLETE® rapid test, Enzyme Immunoassays (EIA) for C. difficile Toxin (A [TcdA], B [TcdB], or both A and B [TcdA/B]) or Cell Cytotoxicity Neutralization Assay (CCNA) within 72 hours prior to randomization.
AND/OR
Presence of a toxigenic strain of C. difficile determined by a locally available FDA cleared Nucleic Acid Amplification Test (NAAT) to detect the presence of either toxin genes or the pathogenicity locus (PaLoc) or Non-FDA cleared tests* within 72 hours prior to randomization.
3. No prior antimicrobial treatment > 30 hours for current episode of CDI.
4. Female subjects of childbearing potential and who are sexually active must be using at least two adequate and reliable methods of contraception (e.g., barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). Females who are postmenopausal (at least one year without menses) will be considered not of childbearing potential.
5. Subjects (both male and female) must agree to avoid conception during the treatment phase and until the end of their participation in the study.

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening.
1. Life-threatening or fulminant CDI with evidence of hypotension [systolic blood pressure less than 90 mmHg], septic shock, peritoneal signs or ileus, or toxic megacolon.
2. Subjects with history of inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
3. Subjects with 2 or more episodes of CDI in the previous year.
4. Females who are pregnant or breastfeeding.
5. Concurrent use of any product which may have a significant affect upon bowel motility (e.g., metoclopramide, narcotics, loperamide) anti-diarrhoeals, anti-peristalics or any product which may slow bowel movement. Chronic and continued use of such products may be allowed during the study if bowel motility has stablised.
6. Participation in other clinical research studies using an investigational product within one month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
7. Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone.
8. Subjects that the Investigator feels are inappropriate for the study will not be included, e.g. subjects with known hypersensitivity or intolerance to SMT19969, fidaxomicin (and the macrolide antibacterial class of compounds) and their excipients; recent use of pro or prebiotics; prior history of faecal microbiota transplant (FMT) or bowel/stomach surgery.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified