Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
- Conditions
- Clostridioides Difficile Infection
- Interventions
- Registration Number
- NCT03595553
- Lead Sponsor
- Summit Therapeutics
- Brief Summary
Summit is developing ridinilazole as a novel antimicrobial for Clostridioides difficile Infection (CDI), formerly known as Clostridium difficile Infection, with the goal of demonstrating an improved Sustained Clinical Response rate in subjects treated with ridinilazole as compared to subjects treated with vancomycin.
A phase 2 proof of concept study, with vancomycin as comparator, demonstrated these attributes with a comparable safety profile. A high fecal concentration of ridinilazole and little systemic exposure were noted.
The rationale for this phase 3 study is to confirm the improvement in sustained clinical response of CDI over vancomycin and to compare the safety and tolerability of ridinilazole to that of vancomycin.
Ridinilazole plasma concentration will be assessed in a subset of patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 759
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description vancomycin Vancomycin vancomycin 125 mg qid ridinilazole Ridinilazole ridinilazole 200mg bid
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Clinical Response (SCR) Defined as Clinical Response and no Recurrence of CDI Through 30 Days Post End of Treatment (EOT). Day 40 This primary outcome measures the number of participants with Sustained Clinical Response (SCR). SCR is defined as Clinical Response and no recurrence of CDI through 30 days post End of Treatment (EOT). At D40, D70 and D100 the Investigator or medically qualified designee will determine if the patient has a sustained clinical response or experienced RECURRENCE since the previous assessment. The Investigator will assess cure/failure and recurrence based on available information which includes, but is not limited to, improvement from baseline in the number of UBMs, signs \& symptoms of CDI, and the requirement for CDI medication. The Investigator should assess cure/failure in a way that best reflects the Investigator's standard clinical practice.
- Secondary Outcome Measures
Name Time Method Clinical Response Day 12 defined as
* less than 3 unformed bowel movements (UBMs) for consecutive days and maintained through EOT without further CDI treatment at EOT + 2 days, or
* the investigator's assessment that the subject no longer needs specific CDI antimicrobial treatment after completion of the course of study medication.Clinical Cure Day 12 defined as the resolution of diarrhea (\<3 UBMs in the 1-day period immediately prior to EOT, that is maintained for 2 days after EOT).
Sustained Clinical Response Over 60 Days Day 70 defined as Clinical Response and no recurrence of CDI through 60 days post EOT
Sustained Clinical Response Over 90 Days Day 100 defined as Clinical Response and no recurrence of CDI through 90 days post EOT
Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT. Day 10 This secondary outcome measures the relative abundance of the 3 main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) from Baseline to EOT.
Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT. Day 10 This secondary outcome measures the percentage of change of α-diversity (Shannon Index) of the microbiota in stool samples from baseline to EOT. Shannon index is a weighted statistic measuring both species richness and evenness. The Shannon Index is calculated by taking the relative abundance of each species and sums the relative abundance times the natural log of the relative abundance for each species. The value is converted into a positive value by times minus one. A higher Shannon Index means higher diversity
Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity). Day 10 This secondary outcome measures the β-diversity of the gut microbiota in stool samples from baseline to EOT. Bray-Curtis index/dissimilarity measures how different two samples are in the microbiome composition. The Bray-Curtis dissimilarity is graded between 0 and 1, where 0 means the two samples have the same composition (that is they share all the species and every species has the same abundance), and 1 means the two samples do not share any species.
Trial Locations
- Locations (149)
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
GI Alliance - Arizona Digestive Health - Sun City
🇺🇸Sun City, Arizona, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Paradigm Clinical Research Centers, Inc
🇺🇸Redding, California, United States
University Of California Davis
🇺🇸Sacramento, California, United States
Midway Immunology and Research Center
🇺🇸Fort Pierce, Florida, United States
Alliance Medical Research LLC
🇺🇸Lighthouse Point, Florida, United States
San Marcus Research
🇺🇸Miami Lakes, Florida, United States
Phoenix Medical Research LLC
🇺🇸Miami, Florida, United States
Scroll for more (139 remaining)University of Alabama - Birmingham🇺🇸Birmingham, Alabama, United States