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Ridinilazole vs Vancomycin for C. difficile Infection
NCT02092935Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2014
- Primary completion
- Oct 2015
- Countries
- 2
- Sponsor
- Summit Therapeutics
- Modality
- Small Molecules
- Drugs
- ridinilazole
- Conditions
- Clostridioides difficile infection (CDI)
01
Overview
Phase 2, randomised, double-blind trial of ridinilazole in Clostridioides difficile infection (CDI) (2 arms), sponsored by Summit Therapeutics. Primary endpoint: Sustained Clinical Response. Started Apr 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SMT19969
Ridinilazole 200 mg BID for 10 days
Vancomycin
Vancomycin 125 mg QID for 10 days
03
Who it enrols
Patients with a clinical diagnosis of CDAD confirmed by laboratory test, excluding those with life-threatening colitis or concurrent antibiotic use.
04
Endpoints
Primary
Sustained Clinical Response
Secondary
Plasma and faecal concentrations of SMT19969
Safety and tolerability of SMT19969 compared with vancomycin
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