Recurrent C. Difficile Infection
Conditions
Keywords
C. difficile infection, recurrent Clostridium difficile infection, Clostriodioides difficile infection, recurrent C. diff infection, multiple recurrent C. diff infection, CDI, c. diff, microbiota transplantation, FMT, Fecal microbiota transplantation, Fecal microbiota transplant, Fecal transplant
Brief summary
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4). This Phase 3 trial will be conducted in 2 parts: a randomized, double-blind, placebo-controlled trial arm and an optional open-label treatment arm. After completing standard-of-care (SOC) CDI antibiotics for their most recent CDI recurrence, patients who meet all eligibility requirements will be randomized in a 2:1 ratio to receive either CP101 or placebo. Patients will be evaluated for CDI recurrence and safety follow-up through Week 8, the primary endpoint, as well as through Week 24. Patients who qualify may enroll into the optional open label arm if they experience CDI recurrence through week 8.
Interventions
BIOLOGICALCP101
CP101 is an investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent Clostridioides difficile infection (CDI).
OTHERPlacebo
Placebo
Sponsors
Finch Research and Development LLC.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent * Men or women over 18 years of age or older * Current diagnosis of a recurrence of non-severe, non-complicated CDI * Subject has a clinical response to standard-of-care CDI antibiotics for the most recent CDI episode * History of recurrent CDI defined as: * ≥ 3 episodes of CDI, with 2 episodes occurring within the previous 6 months (inclusive of the current episode); OR * Patients with a history of 2 episodes of CDI occurring within the previous 6 months (inclusive of the current episode) may be eligible if 65 years of age or older. * For the Qualifying CDI episode, the following criteria must be satisfied: * History of diarrhea (\> 3 unformed stools per day) for 2 or more consecutive days that is clinically consistent with CDI. AND * Documented positive stool test by local laboratory for toxigenic C. difficile (toxin enzyme immunoassay \[EIA\] or polymerase chain reaction \[PCR\]-based testing) for the current CDI episode and within 45 days prior to Randomization. AND * Received a course of SOC CDI antibiotics for the most recent CDI episode (for 10 to 21 days, with exact duration, antibiotic type, and dose at the discretion of the Investigator). AND * Demonstrated an adequate clinical response, defined as ≤ 3 unformed stools in 24 hours for 2 or more consecutive days during SOC CDI antibiotics prior to Randomization.
Exclusion criteria
* Known stool sample testing positive for enteric pathogen(s) (e.g., Salmonella, Shigella, diarrhoeagenic E. coli, Campylobacter, Giardia) within 28 days prior to Screening * Pregnant, breast-feeding, or planning to become pregnant during the trial * Historical or current diagnosis of inflammatory bowel disease * Recent diagnosis (\<6 months prior to screening) of diarrhea-predominant irritable bowel syndrome (post-infection or non-related to an enteric infection) * Initiation of any systemic cancer treatment (e.g., chemotherapy, radiotherapy, biologic, immunotherapy, others) for active malignancy * Major intra-abdominal surgery (e.g., bowel resection) * Known primary or secondary immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Clinical Cure Through Week 8 | Week 8 | No data displayed because Outcome Measure has zero participants analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Clinical Cure Through Week 24 | Week 24 | No data displayed because Outcome Measure has zero participants analyzed. |
| CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture | Week 24 | No data displayed because Outcome Measure has zero participants analyzed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Intestinal Microbiome Diversity at Week 1 as Determined by 16S Ribosomal Ribonucleic Acid (rRNA) Gene Amplicon Sequencing | Week 1 | No data displayed because Outcome Measure has zero participants analyzed. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CP101 CP101: CP101 is an oral investigational microbiome therapeutic designed to deliver a complete and functional microbiome to durably repair intestinal dysbiosis, which is being evaluated for the prevention of recurrent CDI. | 12 |
| Placebo Placebo: Matching placebo capsule | 7 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Clinical Hold | 1 | 0 |
| Overall Study | Study Termination | 6 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CP101 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 64.3 years STANDARD_DEVIATION 14.8 | 66.6 years STANDARD_DEVIATION 15.3 | 65.2 years STANDARD_DEVIATION 14.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 7 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 7 Participants | 17 Participants |
| Region of Enrollment United States | 12 participants | 7 participants | 19 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 0 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 7 |
| other Total, other adverse events | 8 / 12 | 5 / 7 |
| serious Total, serious adverse events | 1 / 12 | 0 / 7 |
Outcome results
Primary
Sustained Clinical Cure Through Week 8
No data displayed because Outcome Measure has zero participants analyzed.
Time frame: Week 8
Population: Study was terminated prematurely; data on primary endpoint are not available; therefore no analysis was conducted because there was no data to analyze.
Secondary
CDI Recurrence Through Week 24 as Evidenced by Positive Toxin EIA or Positive Toxigenic Culture
No data displayed because Outcome Measure has zero participants analyzed.
Time frame: Week 24
Population: Study was terminated prematurely; EIA testing was not performed on samples collected; therefore the analysis was not conducted because no data was available to analyze.
Secondary
Sustained Clinical Cure Through Week 24
No data displayed because Outcome Measure has zero participants analyzed.
Time frame: Week 24
Population: Study was terminated prematurely; no data on secondary endpoint were available; therefore the analysis was not conducted because there are no data to analyze.
Other Pre-specified
Improvement of Intestinal Microbiome Diversity at Week 1 as Determined by 16S Ribosomal Ribonucleic Acid (rRNA) Gene Amplicon Sequencing
No data displayed because Outcome Measure has zero participants analyzed.
Time frame: Week 1
Population: Study was terminated prematurely; Microbiome sample testing was not performed; therefore the analysis was not conducted because no data were available to analyze.