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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMT19969 | Experimental | 200 mg capsule of SMT19969 twice a day for 10 days with alternating 200 mg placebo twice a day |
|
| Vancomycin | Active Comparator | 125 mg capsule four times a day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMT19969 | Drug |
| ||
| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical outcome by assessment of sustained clinical response | Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy | 30 days post End of Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and faecal concentrations of SMT19969 | Using laboratory analysis | 40 Days |
| To assess the safety and tolerability of SMT19969 compared with vancomycin | Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the qualitative and quantitative effect of SMT19969 and Vancomycin on the bowel flora of subjects | Using microbiology, sequencing, metagenomic and bioinformatics techniques. | 40 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Vickers, PhD | Summit (Oxford) Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29718329 | Derived | Snydman DR, McDermott LA, Thorpe CM, Chang J, Wick J, Walk ST, Vickers RJ. Antimicrobial susceptibility and ribotypes of Clostridium difficile isolates from a Phase 2 clinical trial of ridinilazole (SMT19969) and vancomycin. J Antimicrob Chemother. 2018 Aug 1;73(8):2078-2084. doi: 10.1093/jac/dky135. | |
| 28461207 | Derived |
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|
| 40 days |
| Laguna Hills |
| California |
| United States |
| Long Beach | California | United States |
| Sylmar | California | United States |
| Ventura | California | United States |
| Idaho Falls | Idaho | United States |
| Chicago | Illinois | United States |
| Topeka | Kansas | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Duluth | Minnesota | United States |
| Minneapolis | Minnesota | United States |
| Tupelo | Mississippi | United States |
| Billings | Montana | United States |
| Butte | Montana | United States |
| Sommers Point | New Jersey | United States |
| Rochester | New York | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Lima | Ohio | United States |
| Rapid City | South Dakota | United States |
| Seattle | Washington | United States |
| Hamilton | Ontario | Canada |
| Montreal | Quebec | Canada |
| Vickers RJ, Tillotson GS, Nathan R, Hazan S, Pullman J, Lucasti C, Deck K, Yacyshyn B, Maliakkal B, Pesant Y, Tejura B, Roblin D, Gerding DN, Wilcox MH; CoDIFy study group. Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Lancet Infect Dis. 2017 Jul;17(7):735-744. doi: 10.1016/S1473-3099(17)30235-9. Epub 2017 Apr 28. |
| 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 |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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