Trial Outcomes & Findings for A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4) (NCT NCT05153499)
NCT ID: NCT05153499
Last Updated: 2023-11-13
Results Overview
No data displayed because Outcome Measure has zero participants analyzed.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
19 participants
Primary outcome timeframe
Week 8
Results posted on
2023-11-13
Participant Flow
Participant milestones
| Measure |
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.
|
Placebo
Placebo: Matching placebo capsule
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
7
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
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.
|
Placebo
Placebo: Matching placebo capsule
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Clinical Hold
|
1
|
0
|
|
Overall Study
Study Termination
|
6
|
5
|
Baseline Characteristics
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
Baseline characteristics by cohort
| Measure |
CP101
n=12 Participants
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.
|
Placebo
n=7 Participants
Placebo: Matching placebo capsule
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
66.6 years
STANDARD_DEVIATION 15.3 • n=7 Participants
|
65.2 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
7 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: Study was terminated prematurely; data on primary endpoint are not available; therefore no analysis was conducted because there was no data to analyze.
No data displayed because Outcome Measure has zero participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: Study was terminated prematurely; no data on secondary endpoint were available; therefore the analysis was not conducted because there are no data to analyze.
No data displayed because Outcome Measure has zero participants analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 24Population: 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.
No data displayed because Outcome Measure has zero participants analyzed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 1Population: Study was terminated prematurely; Microbiome sample testing was not performed; therefore the analysis was not conducted because no data were available to analyze.
No data displayed because Outcome Measure has zero participants analyzed.
Outcome measures
Outcome data not reported
Adverse Events
CP101
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CP101
n=12 participants at risk
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.
|
Placebo
n=7 participants at risk
Placebo: Matching placebo capsule
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Injury, poisoning and procedural complications
Subdural Haemotoma
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
Other adverse events
| Measure |
CP101
n=12 participants at risk
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.
|
Placebo
n=7 participants at risk
Placebo: Matching placebo capsule
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Anal incontinence
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 2 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
General disorders
Chills
|
16.7%
2/12 • Number of events 2 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
General disorders
Pyrexia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
General disorders
Pain
|
0.00%
0/12 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Infections and infestations
COVID-19
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Infections and infestations
Genital herpes
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/12 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
0.00%
0/7 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a minimum of 30 days following treatment. Due to the early termination of the study, the longest follow-up period was 232 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restrictions on the PI are: (i) the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to twenty-four months from the lock-down of all study data and (ii) the sponsor can require the removal of its confidential information from results communications and may delay release for a period of up to 60 days for the purpose of filing patent applications.
- Publication restrictions are in place
Restriction type: OTHER