A Study of Ridinilazole (SMT19969) Compared With Fidaxomicin for the Treatment of Clostridium Difficile Infection (CDI)

Clostridium Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784002
• Other study ID #: SMT19969/C003
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2016
• Last updated: October 3, 2017
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: October 2017
• Source: Summit Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Communicable Diseases
• Infection

Intervention

Drug:
• Ridinilazole

• Fidaxomicin

Locations

Country	Name	City	State
Czechia	Liberec	Liberec
Czechia	Pardubice	Pardubice
Czechia	Praha	Praha
Czechia	Zlin	Zlin
United Kingdom	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 States	Butte	Butte	Montana
United States	Idaho	Idaho Falls	Idaho
United States	Laguna Hills	Laguna Hills	California
United States	New Jersey	Somers Point	New Jersey
United States	Ventura	Ventura	California

Sponsors (1)

Lead Sponsor	Collaborator
Summit Therapeutics

Countries where clinical trial is conducted

United States,  Czechia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events (AEs) and serious adverse events (SAEs) to evaluate safety and tolerability		30 days post End of Therapy
Secondary	To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969		12 days
Secondary	To assess the qualitative and quantitative effect on the bowel flora of each subject using 16S ribosomal RNA sequencing, metagenomics and bioinformatic techniques		40 days
Secondary	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
Secondary	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