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

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ClinicalTrials.gov Identifier: NCT02784002
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Summit Therapeutics

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

Condition or disease Intervention/treatment Phase
Clostridium Difficile Infection Drug: Ridinilazole Drug: Fidaxomicin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Fidaxomicin

Arm Intervention/treatment
Experimental: Ridinilazole (SMT19969)
200 mg capsule of Ridinilazole (SMT19969) twice a day for 10 days
Drug: Ridinilazole
Other Name: SMT19969

Active Comparator: Fidaxomicin
200 mg tablet of Fidaxomicin twice a day for 10 days
Drug: Fidaxomicin



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. To assess the pharmacokinetics of SMT19969 in patients with CDI by measuring the plasma, urine and fecal concentrations of SMT19969 [ Time Frame: 12 days ]
  2. 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 ]
  3. Measure clinical cure rates at the Test of Cure (TOC) visit [ Time Frame: 12 days ]
    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.

  4. Measure sustained clinical response (SCR) rates [ Time Frame: 40 days ]
    SCR is defined as clinical cure at TOC and no recurrence of CDI within 30 days post end of treatment (EOT).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784002


Locations
United States, California
Laguna Hills
Laguna Hills, California, United States, 92653
Ventura
Ventura, California, United States, 93003
United States, Idaho
Idaho
Idaho Falls, Idaho, United States, 83404
United States, Montana
Butte
Butte, Montana, United States, 59701
United States, New Jersey
New Jersey
Somers Point, New Jersey, United States, 08244
Czechia
Liberec
Liberec, Czechia
Pardubice
Pardubice, Czechia
Praha
Praha, Czechia
Zlin
Zlin, Czechia
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 Kingdom
Sponsors and Collaborators
Summit Therapeutics
Investigators
Study Director: Medical Director Summit Therapeutics

Responsible Party: Summit Therapeutics
ClinicalTrials.gov Identifier: NCT02784002     History of Changes
Other Study ID Numbers: SMT19969/C003
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Infection
Communicable Diseases