Enterocolitis Clostridium Difficile Recurrent
Conditions
Keywords
Clostridium difficile, C diff, CDI, CDAD, Fecal transplant, Fecal Microbiota Transplant, Diarrhea, FMT, Microbiota restoration therapy, Microbiota suspension, Fecal bacteriotherapy, C diff diarrhea
Brief summary
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Detailed description
This is the first prospective, multi-center, double-blinded, randomized controlled study of a microbiota suspension derived from intestinal microbes. The primary assessments for this study are (i) efficacy of RBX2660 compared to placebo at 8 weeks and (ii) safety via assessment of adverse events. Study visits are at 1-, 4- and 8-weeks after treatment with additional follow-up at 3, 6 12 and 24 months post treatment. Patients who have had at least two recurrences of C. difficile infection (CDI) after a primary episode and have completed at least two rounds of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Patients whose CDI returns in less than 8 weeks after the last assigned study treatment may be eligible to receive up to 2 treatments with RBX2660 in the open-label portion of the study.
Interventions
BIOLOGICALRBX2660 (microbiota suspension)
A suspension of intestinal microbes
OTHERPlacebo
A suspension of saline and cryoprotectant
Sponsors
Rebiotix Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years * Medical record documentation of recurrent CDI either: a) at least two recurrences after a primary episode and has completed at least two rounds of standard-of-care oral antibiotic therapy or b) has had at least two episodes of severe CDI resulting in hospitalization. * Documented history that the subject's recurrent CDI is controlled while on antibiotics even if the subject is not currently on antibiotics. * A positive stool test for the presence of C. difficile within 60 days prior to enrollment.
Exclusion criteria
* A known history of continued C. difficile diarrhea while taking on a course of antibiotics prescribed for CDI treatment. * Requires antibiotic therapy for a condition other than recurrent CDI. * Previous fecal transplant prior to study enrollment. * History of inflammatory bowel disease (IBD), e.g., ulcerative colitis, Crohn's disease, or microscopic colitis. * History of irritable bowel syndrome (IBS). * History of chronic diarrhea. * History of celiac disease. * Colostomy. * Planned surgery requiring perioperative antibiotics within 6 months of study enrollment. * Life expectancy of \< 12 months. * Compromised immune system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) | 8 weeks after last assigned study treatment | The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) | 8-weeks | Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema. |
| SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | 8-week | The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL. |
| Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) | 8-weeks | Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema |
| Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | 8-weeks | Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema. |
| Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | 8-weeks | Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema. |
| Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | 8-weeks | Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema. |
Countries
Canada, United States
Participant flow
Recruitment details
Recruitment was from 12/10/14 to 11/13/15 at 21 medical clinics in the United States and Canada. Recruiment was performed by trained investigators and study coordinators.
Pre-assignment details
Seventeen enrolled subjects did not proceed to randomization and were exited from the study. Of the 133 randomized subjects remaining, five subjects chose to withdraw prior to treatment and in one subject the first blinded enema was not able to be initiated due to anxiety and the subject subsequently chose to withdraw.
Participants by arm
| Arm | Count |
|---|---|
| Group A Two enemas of RBX2660 administered 7 days apart
RBX2660 (microbiota suspension): A suspension of intestinal microbes | 45 |
| Group B Two enemas of placebo administered 7 days apart
Placebo: A suspension of saline and cryoprotectant | 44 |
| Group C 1 enema of RBX2660 and 1 enema of placebo administered 7 days apart
RBX2660 (microbiota suspension): A suspension of intestinal microbes
Placebo: A suspension of saline and cryoprotectant | 44 |
| Total | 133 |
Baseline characteristics
| Characteristic | Group B | Group C | Total | Group A |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 18 Participants | 63 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 69 Participants | 19 Participants |
| Age, Continuous | 58.8 years STANDARD_DEVIATION 19.24 | 61.0 years STANDARD_DEVIATION 19.69 | 61.1 years STANDARD_DEVIATION 19.31 | 63.6 years STANDARD_DEVIATION 19.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 42 Participants | 127 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 43 Participants | 42 Participants | 129 Participants | 44 Participants |
| Region of Enrollment Canada | 8 participants | 8 participants | 28 participants | 12 participants |
| Region of Enrollment United States | 36 participants | 36 participants | 105 participants | 33 participants |
| Sex: Female, Male Female | 30 Participants | 25 Participants | 81 Participants | 26 Participants |
| Sex: Female, Male Male | 14 Participants | 19 Participants | 52 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 42 | 2 / 44 | 6 / 42 |
| other Total, other adverse events | 24 / 42 | 19 / 44 | 20 / 42 |
| serious Total, serious adverse events | 18 / 42 | 8 / 44 | 12 / 42 |
Outcome results
Primary
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT)
The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).
Time frame: 8 weeks after last assigned study treatment
Population: ITT - Subjects in the ITT that were randomized, but not treated, as well as subjects with an indeterminate treatment outcome, were also conservatively treated as treatment failures.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) | Treatment Failure | 20 Participants |
| Group A | Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) | Treatment Success | 25 Participants |
| Group B | Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) | Treatment Failure | 25 Participants |
| Group B | Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) | Treatment Success | 19 Participants |
Secondary
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT)
The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.
Time frame: 8-week
Population: ITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Baseline | 39.4 Score on a scale | Standard Deviation 11.4 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 1 | 44.3 Score on a scale | Standard Deviation 10.2 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 4 | 44.9 Score on a scale | Standard Deviation 11.6 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 8 | 43.9 Score on a scale | Standard Deviation 10.9 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Baseline | 44.6 Score on a scale | Standard Deviation 13.5 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 1 | 51.8 Score on a scale | Standard Deviation 10.5 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 4 | 53.5 Score on a scale | Standard Deviation 10.7 |
| Group A | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 8 | 52.1 Score on a scale | Standard Deviation 10.8 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 4 | 45.6 Score on a scale | Standard Deviation 10.2 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 4 | 48.2 Score on a scale | Standard Deviation 12.4 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 8 | 45.8 Score on a scale | Standard Deviation 10.6 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Baseline | 42.5 Score on a scale | Standard Deviation 11.5 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 1 | 51.2 Score on a scale | Standard Deviation 10.3 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Baseline | 39.4 Score on a scale | Standard Deviation 9.7 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 1 | 45.0 Score on a scale | Standard Deviation 9.7 |
| Group B | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 8 | 49.8 Score on a scale | Standard Deviation 11.7 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 4 | 46.1 Score on a scale | Standard Deviation 11.2 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 1 | 46.4 Score on a scale | Standard Deviation 10.1 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Baseline | 43.4 Score on a scale | Standard Deviation 10.5 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Physical Comp Week 8 | 46.5 Score on a scale | Standard Deviation 12.1 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 4 | 51.5 Score on a scale | Standard Deviation 6.4 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 1 | 50.6 Score on a scale | Standard Deviation 8.2 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Baseline | 45.0 Score on a scale | Standard Deviation 11.9 |
| Group C | SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) | Mental Comp Week 8 | 51.2 Score on a scale | Standard Deviation 7.6 |
Secondary
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT)
Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time frame: 8-weeks
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 7 | 73.3 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 35 | 57.8 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 21 | 60.0 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 42 | 57.8 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 14 | 66.7 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 49 | 55.5 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 28 | 60.0 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 56 | 55.5 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 0 | 91.1 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 56 | 42.2 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 0 | 100 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 7 | 77.3 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 14 | 63.6 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 21 | 61.4 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 28 | 56.8 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 35 | 52.3 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 42 | 50.0 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) | % Recurrence Free by Day 49 | 47.6 percentage of participants |
Secondary
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT)
Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time frame: 8-weeks
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 7 | 73.3 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 35 | 57.8 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 21 | 60.0 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 42 | 57.8 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 14 | 66.7 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 49 | 55.5 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 28 | 60.0 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 56 | 55.5 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by 2nd Enema | 91.1 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 56 | 55.9 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by 2nd Enema | 95.5 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 7 | 76.9 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 14 | 69.9 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 21 | 62.9 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 28 | 62.9 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 35 | 60.6 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 42 | 55.9 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) | % Recurrence Free by Day 49 | 55.9 percentage of participants |
Secondary
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT)
Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.
Time frame: 8-weeks
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 7 | 76.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 35 | 60.6 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 21 | 62.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 42 | 55.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 14 | 69.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 49 | 55.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 28 | 62.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 56 | 55.9 percentage of participants |
| Group A | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by 2nd Enema | 95.5 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 56 | 42.2 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by 2nd Enema | 100 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 7 | 77.3 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 14 | 63.6 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 21 | 61.4 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 28 | 56.8 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 35 | 52.3 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 42 | 50.0 percentage of participants |
| Group B | Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) | % Recurrence Free by Day 49 | 47.6 percentage of participants |
Secondary
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT)
Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema
Time frame: 8-weeks
Population: ITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) | Success | 19 Participants |
| Group A | Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) | Failure | 25 Participants |
| Group B | Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) | Success | 25 Participants |
| Group B | Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) | Failure | 19 Participants |
Secondary
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT)
Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.
Time frame: 8-weeks
Population: ITT
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) | Success | 25 Participants |
| Group A | Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) | Failure | 20 Participants |
| Group B | Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) | Success | 25 Participants |
| Group B | Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) | Failure | 19 Participants |