A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate the safety and effectiveness of Ridinilazole (SMT19969) in treating C. difficile Infection (CDI).

Official Title
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A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200mg BID) for 10 Days Compared With Fidaxomicin (200 mg BID) for 10 Days for the Treatment of Clostridium Difficile Infection (CDI)

Conditions
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Clostridium Difficile Infection

Intervention / Treatment
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* Drug: Ridinilazole
* Drug: Fidaxomicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Clinical diagnosis of CDI plus laboratory diagnostic test No more than 30 hours antimicrobial treatment for current CDI episode Female subjects of childbearing potential must use adequate contraception Exclusion Criteria: Life-threatening or fulminant CDI Subjects with 2 or more episodes of CDI in the previous year Females who are pregnant or breastfeeding History of inflammatory bowel disease Co-administration of potent P-glycoprotein inhibitors Participation in other Clinical research studies within one month of screening Subjects that the Investigator feels are inappropriate for the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ridinilazole (SMT19969)<br>200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days | Drug: Ridinilazole<br> <br> * Other names: SMT19969;|
| Active Comparator: Fidaxomicin<br>200 mg tablet of Fidaxomicin twice a day for 10 days | Drug: Fidaxomicin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability |  | 30 days post End of Therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969 |  | 12 days | 
| To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques |  | 40 days | 
| Measure clinical cure rates at the Test of Cure (TOC) visit | Investigator assessed clinical response at the TOC visit (on day 12) with clinical cure defined as the resolution of diarrhoea (≤ 3 Unformed Bowel Movements (UBMs) per day) while on treatment that is maintained until the TOC visit. | 12 days | 
| Measure sustained clinical response (SCR) rates | SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT). | 40 days |