This trial is active, not recruiting.

Condition clostridium difficile infection
Treatments ridinilazole, fidaxomicin
Phase phase 2
Sponsor Summit Therapeutics
Start date December 2014
End date December 2016
Trial size 30 participants
Trial identifier NCT02784002, SMT19969/C003


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
ridinilazole SMT19969
(Active Comparator)
200 mg tablet of Fidaxomicin twice a day for 10 days

Primary Outcomes

Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability
time frame: 30 days post End of Therapy

Secondary Outcomes

To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
time frame: 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
time frame: 40 days
Measure clinical cure rates at the Test of Cure (TOC) visit
time frame: 12 days
Measure sustained clinical response (SCR) rates
time frame: 40 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Summit Therapeutics.