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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridinilazole (SMT19969) | Experimental | 200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days |
|
| Fidaxomicin | Active Comparator | 200 mg tablet of Fidaxomicin twice a day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridinilazole | Drug |
|
| |
| Fidaxomicin |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Summit Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laguna Hills | Laguna Hills | California | 92653 | United States | ||
| Ventura |
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| Drug |
|
| 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 |
| Ventura |
| California |
| 93003 |
| United States |
| Idaho | Idaho Falls | Idaho | 83404 | United States |
| Butte | Butte | Montana | 59701 | United States |
| New Jersey | Somers Point | New Jersey | 08244 | United States |
| Liberec | Liberec | Czechia |
| Pardubice | Pardubice | Czechia |
| Praha | Prague | Czechia |
| Zlin | Zlín | Czechia |
| Leeds | Leeds | United Kingdom |
| Liverpool | Liverpool | United Kingdom |
| London | London | United Kingdom |
| Manchester | Manchester | United Kingdom |
| Newcastle Upon Tyne | Newcastle upon Tyne | United Kingdom |
| Oxford | Oxford | United Kingdom |
| Wigan | Wigan | United Kingdom |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000601750 | ridinilazole |
| D000077732 | Fidaxomicin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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