Clinical trial NCT02784002: A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile Infection
Lead sponsor: Summit Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability
timeFrame: 30 days post End of Therapy
Secondary outcomes:
measure: To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969
timeFrame: 12 days
measure: To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques
timeFrame: 40 days
measure: Measure clinical cure rates at the Test of Cure (TOC) visit
timeFrame: 12 days
measure: Measure sustained clinical response (SCR) rates
timeFrame: 40 days
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Laguna Hills
state: California
city: Ventura
country: United States
facility: Ventura
state: California
city: Idaho Falls
country: United States
facility: Idaho
state: Idaho
city: Butte
country: United States
facility: Butte
state: Montana
city: Somers Point
country: United States
facility: New Jersey
state: New Jersey
city: Liberec
country: Czechia
facility: Liberec
city: Pardubice
country: Czechia
facility: Pardubice
city: Praha
country: Czechia
facility: Praha
city: Zlin
country: Czechia
facility: Zlin
city: Leeds
country: United Kingdom
facility: Leeds
city: Liverpool
country: United Kingdom
facility: Liverpool
city: London
country: United Kingdom
facility: London
city: Manchester
country: United Kingdom
facility: Manchester
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Upon Tyne
city: Oxford
country: United Kingdom
facility: Oxford
city: Wigan
country: United Kingdom
facility: Wigan
Study officials:
affiliation: Summit Therapeutics
name: Medical Director
role: STUDY_DIRECTOR
References: