Brief Summary
The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).
Brief Title
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Clostridium Difficile Infection
Eligibility Criteria
Inclusion Criteria:
* Informed consent
* Clinical diagnosis of CDAD plus laboratory diagnostic test
* No more than 24 hrs antimicrobial treatment for current CDAD episode
* No more than 3 episodes of CDAD in prior 12 months
* No previous episode of CDAD within 30 days of study enrollment
* Female subjects of childbearing potential must use adequate contraception
Exclusion Criteria:
* Life-threatening or fulminant colitis
* Concurrent use of antibiotics or any other treatments for CDAD
* History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
* Participation in other Clinical research studies within one month of screening
* Informed consent
* Clinical diagnosis of CDAD plus laboratory diagnostic test
* No more than 24 hrs antimicrobial treatment for current CDAD episode
* No more than 3 episodes of CDAD in prior 12 months
* No previous episode of CDAD within 30 days of study enrollment
* Female subjects of childbearing potential must use adequate contraception
Exclusion Criteria:
* Life-threatening or fulminant colitis
* Concurrent use of antibiotics or any other treatments for CDAD
* History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
* Participation in other Clinical research studies within one month of screening
Inclusion Criteria
Inclusion Criteria:
* Informed consent
* Clinical diagnosis of CDAD plus laboratory diagnostic test
* No more than 24 hrs antimicrobial treatment for current CDAD episode
* No more than 3 episodes of CDAD in prior 12 months
* No previous episode of CDAD within 30 days of study enrollment
* Female subjects of childbearing potential must use adequate contraception
* Informed consent
* Clinical diagnosis of CDAD plus laboratory diagnostic test
* No more than 24 hrs antimicrobial treatment for current CDAD episode
* No more than 3 episodes of CDAD in prior 12 months
* No previous episode of CDAD within 30 days of study enrollment
* Female subjects of childbearing potential must use adequate contraception
Gender
All
Gender Based
false
Keywords
CDAD
Clostridium Difficile
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
90 Years
Minimum Age
18 Years
NCT Id
NCT02092935
Org Class
Industry
Org Full Name
Summit Therapeutics
Org Study Id
SMT19969/C002
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase II, Randomized, Double-Blind, Active-Controlled Clinical Study to Investigate the Efficacy and Safety of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)
Primary Outcomes
Outcome Description
Sustained clinical response is defined as clinical cure at the Test of Cure Visit (Day 12) and no recurrence of CDAD within 30 days of End of Therapy
Outcome Measure
Evaluate the clinical outcome by assessment of sustained clinical response
Outcome Time Frame
30 days post End of Therapy
Secondary Outcomes
Outcome Description
Using laboratory analysis
Outcome Time Frame
40 Days
Outcome Measure
Plasma and faecal concentrations of SMT19969
Outcome Description
Assessment of the Adverse Events (AEs) and Serious Adverse Events (SAEs) reported within the study
Outcome Time Frame
40 days
Outcome Measure
To assess the safety and tolerability of SMT19969 compared with vancomycin
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
90
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Paul Riska
Investigator Email
priska@montefiore.org
Investigator Phone
718-020-6494