Trial · NCT03595553

Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection

NCT03595553, Phase 3, Completed, Summit Therapeutics; results first posted 2023-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection. Trials, record NCT03595553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03595553

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Ridinilazole Versus Vancomycin Treatment for Clostridium Difficile Infection
NCT number: NCT03595553
Status: Completed
Phases: Phase 3
Enrollment: 759 participants, actual
Lead sponsor: Summit Therapeutics
Conditions: Clostridioides Difficile Infection
Interventions: Ridinilazole, Vancomycin
First posted: 2018-07-23
Last updated: 2026-10-09
Results first posted: 2023-03-03

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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.
Secondary	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).
Secondary	Sustained Clinical Response Over 60 Days	Day 70	defined as Clinical Response and no recurrence of CDI through 60 days post EOT
Secondary	Sustained Clinical Response Over 90 Days	Day 100	defined as Clinical Response and no recurrence of CDI through 90 days post EOT
Secondary	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.
Secondary	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
Secondary	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	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	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Response	Day 12	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Cure	Day 12	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Sustained Clinical Response Over 60 Days	Day 70	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Sustained Clinical Response Over 90 Days	Day 100	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Relative Abundance of the 3 Main Bile Acid Groups (Conjugated Primary, Primary and Secondary Bile Acids) From Baseline to EOT.	Day 10	percentage of abundance	MEAN
SECONDARY	Percentage of Change of α-diversity (Shannon Index) of the Microbiota in Stool Samples From Baseline to EOT.	Day 10	percent change in Shannon Index	MEAN
SECONDARY	Measure of β-diversity of the Gut Microbiota Between Baseline and EOT Stool Samples (Bray-Curtis Index/Dissimilarity).	Day 10	Bray-Curtis Index	MEAN

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
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).	Ridinilazole	SCR based on Clinical Cure	238	Participants
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).	Vancomycin	SCR based on Clinical Cure	225	Participants
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).	Ridinilazole	SCR based on Clinical Cure Failure	132	Participants
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).	Vancomycin	SCR based on Clinical Cure Failure	150	Participants
Clinical Response	Ridinilazole	Clinical Response	320	Participants
Clinical Response	Vancomycin	Clinical Response	346	Participants
Clinical Response	Ridinilazole	Clinical Response Failure	50	Participants
Clinical Response	Vancomycin	Clinical Response Failure	29	Participants
Clinical Cure	Ridinilazole	Clinical Cure	275	Participants
Clinical Cure	Vancomycin	Clinical Cure	292	Participants

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Ridinilazole	370
Overall Study	STARTED	Vancomycin	375
Overall Study	COMPLETED	Ridinilazole	312
Overall Study	COMPLETED	Vancomycin	327
Overall Study	NOT COMPLETED	Ridinilazole	58
Overall Study	NOT COMPLETED	Vancomycin	48

Source ClinicalTrials.gov

Adverse events558

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Abdominal discomfort	Gastrointestinal disorders	RIDINILAZOLE 200 MG	1	374	1
other	Abdominal discomfort	Gastrointestinal disorders	VANCOMYCIN 125 MG	0	377	0
other	Abdominal distension	Gastrointestinal disorders	RIDINILAZOLE 200 MG	4	374	4
other	Abdominal distension	Gastrointestinal disorders	VANCOMYCIN 125 MG	0	377	0
other	Abdominal pain	Gastrointestinal disorders	RIDINILAZOLE 200 MG	7	374	9
other	Abdominal pain	Gastrointestinal disorders	VANCOMYCIN 125 MG	7	377	7
other	Abdominal pain lower	Gastrointestinal disorders	RIDINILAZOLE 200 MG	1	374	1
other	Abdominal pain lower	Gastrointestinal disorders	VANCOMYCIN 125 MG	0	377	0
other	Abdominal pain upper	Gastrointestinal disorders	RIDINILAZOLE 200 MG	5	374	5
other	Abdominal pain upper	Gastrointestinal disorders	VANCOMYCIN 125 MG	0	377	0

1 to 10 of 558Source ClinicalTrials.gov

See all 558 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	RIDINILAZOLE 200 MG	26	374
Total, all-cause mortality	VANCOMYCIN 125 MG	24	377
Total, other adverse events	RIDINILAZOLE 200 MG	124	374
Total, other adverse events	VANCOMYCIN 125 MG	117	377
Total, serious adverse events	RIDINILAZOLE 200 MG	32	374
Total, serious adverse events	VANCOMYCIN 125 MG	30	377

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30767587	DERIVED	PubMed
38305378	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
RIDINILAZOLE 200 MG vs VANCOMYCIN 125 MG: deaths from any cause	Trial comparisons
RIDINILAZOLE 200 MG vs VANCOMYCIN 125 MG: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03595553

GET https://conductscience.org/api/trials/v1/NCT03595553/results?page=2

API reference For AI assistants