Trial Outcomes & Findings for Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection (NCT NCT04781387)
NCT ID: NCT04781387
Last Updated: 2025-06-13
Results Overview
Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., \<3 unformed bowel movements \[UBM\] \[Bristol Stool Scale score of 5, 6, or 7\] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day 12 visit.
COMPLETED
PHASE2
43 participants
TOC/Day 12
2025-06-13
Participant Flow
Participant milestones
| Measure |
CRS3123 200 Milligram
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
14
|
|
Overall Study
COMPLETED
|
12
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
CRS3123 200 Milligram
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of CRS3123 vs. Oral Vancomycin in Adult Patients With Clostridioides Difficile Infection
Baseline characteristics by cohort
| Measure |
CRS3123 200 Milligram
n=14 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=15 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=14 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
27 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=93 Participants
|
6 participants
n=4 Participants
|
5 participants
n=27 Participants
|
15 participants
n=483 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
9 participants
n=4 Participants
|
9 participants
n=27 Participants
|
28 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: TOC/Day 12Population: ITT: All randomized participants
Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., \<3 unformed bowel movements \[UBM\] \[Bristol Stool Scale score of 5, 6, or 7\] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day 12 visit.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=14 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=15 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=14 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
Clinical Cure
|
13 Participants
|
15 Participants
|
13 Participants
|
|
Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
Clinical Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Clinical Cure at the Test of Cure [TOC] Visit in the Intent-to-treat [ITT] Population
Indeterminate
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: TOC/Day 12Population: mITT: Participants in the ITT population who have Cdiff isolated in culture and who are Cdiff toxin positive from a screening or Day 1 fecal sample
Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., \<3 unformed bowel movements \[UBM\] \[Bristol Stool Scale score of 5, 6, or 7\] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day12 visit.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=13 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
Clinical Cure
|
12 Participants
|
14 Participants
|
13 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
Clinical Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
Indeterminant
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: TOC/Day 12Population: PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations
Clinical cure is defined as survival through TOC/Day 12 and resolution of diarrhea (i.e., \<3 unformed bowel movements \[UBM\] \[Bristol Stool Scale score of 5, 6, or 7\] at end-of-treatment (EOT)/Day 10 with maintenance of resolution through TOC/Day 12 and no further requirement for treatment of CDI through TOC/Day 12. Numbers reported below indicate participants from each cohort that were clinical cures, clinical failures, or indeterminate at the TOC/Day12 visit.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Clinical Cure
|
12 Participants
|
14 Participants
|
13 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Clinical Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Clinical Cure
|
12 Participants
|
14 Participants
|
13 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Clinical Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Clinical Cure at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: TOC/Day 12Population: mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample
Total relief of symptoms at TOC/Day 12 is defined as resolution (\< 3 per day) of unformed bowel movements, an investigator's assessment of clinical cure, and the resolution of signs or symptoms of CDI recorded at baseline. Numbers reported below indicate participants from each cohort that had total relief of symptoms at TOC/Day 12 and those that did not.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=13 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
Total Relief of Symptoms -- Yes
|
11 Participants
|
14 Participants
|
12 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
Total Relief of Symptoms -- No
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
Total Relief of Symptoms -- Indeterminate
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: TOC/Day 12Population: PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations
Total relief of symptoms at TOC/Day 12 is defined as resolution (\< 3 per day) of unformed bowel movements, an investigator's assessment of clinical cure, and the resolution of signs or symptoms of CDI recorded at baseline. Numbers reported below indicate participants from each cohort that had total relief of symptoms at TOC/Day 12 and those that did not.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Total Relief of Symptoms -- Yes
|
11 Participants
|
14 Participants
|
12 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Total Relief of Symptoms -- No
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Total Relief of Symptoms -- Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Total Relief of Symptoms -- Yes
|
11 Participants
|
14 Participants
|
12 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Total Relief of Symptoms -- No
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Rate of Total Relief of Symptoms of Clostridioides Difficile Infection at Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Total Relief of Symptoms -- Indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study Day 1 until the date of documented resolution, assessed up to TOC/Day 12Population: mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample
The time to resolution of diarrhea is defined as the time elapsed from the first dose of study treatment to the last unformed bowel movement before 2 consecutive days of \< 3 unformed bowel movements (Bristol Stool Scale score of 5, 6, or 7) per day through TOC/Day 12. Values reported below are median days to resolution for each cohort.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=13 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Microbiological-ITT (mITT) Population
|
2.6 Days
Interval 0.9 to 3.4
|
3.9 Days
Interval 1.2 to 4.6
|
1.9 Days
Interval 0.0 to 4.7
|
SECONDARY outcome
Timeframe: Study Day 1 until the date of documented resolution, assessed up to TOC/Day 12Population: PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations
The time to resolution of diarrhea is defined as the time elapsed from the first dose of study treatment to the last unformed bowel movement before 2 consecutive days of \< 3 unformed bowel movements (Bristol Stool Scale score of 5, 6, or 7) per day through TOC/Day 12. Values reported below are median days to resolution for each cohort.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP
|
2.7 Days
Interval 0.9 to 4.0
|
3.9 Days
Interval 1.2 to 4.6
|
1.9 Days
Interval 0.0 to 4.7
|
|
Time to Resolution of Diarrhea Through Test of Cure (TOC) in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME
|
2.7 Days
Interval 0.9 to 4.0
|
3.9 Days
Interval 1.2 to 4.6
|
1.9 Days
Interval 0.0 to 4.7
|
SECONDARY outcome
Timeframe: Post TOC/Day 12 visit through Day 40Population: mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample
Rate of early recurrence of C. difficile infection (CDI) is defined as a new episode of diarrhea (≥ 3 unformed bowel movements \[Bristol Stool Scale score of 5, 6, or 7\] in a 24-hour period) with a positive toxin result and requires retreatment for CDI before Day 40. The table below shows the number of participants per cohort that experienced a recurrence before Day 40 and those that did not. Only participants that were clinical cures at TOC/Day 12 were included in the analysis.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiological-ITT (mITT) Population
Recurrence -- Yes
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiological-ITT (mITT) Population
Recurrence -- No
|
12 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post TOC/Day 12 visit through Day 40Population: ME: Participants in the PP and Micro-ITT populations
Rate of early recurrence of C. difficile infection (CDI) is defined as a new episode of diarrhea (≥ 3 unformed bowel movements \[Bristol Stool Scale score of 5, 6, or 7\] in a 24-hour period) with a positive toxin result and requires retreatment for CDI before Day 40. The table below shows the number of participants per cohort that experienced a recurrence before Day 40 and those that did not. Only participants that were clinical cures at TOC/Day 12 were included in the analysis.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiologically Evaluable (ME) Population
Recurrence -- Yes
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Rate of Early Recurrence of Clostridioides Difficile Infection Through Day 40 in the Microbiologically Evaluable (ME) Population
Recurrence -- No
|
12 Participants
|
13 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 40 - Day 70Population: mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample
Rate of late recurrence of CDI is defined as a new episode of diarrhea (≥ 3 unformed bowel movements \[Bristol Stool Scale score of 5, 6, or 7\] in a 24-hour period), with a positive toxin result and requires retreatment of CDI between Day 40 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between Day 40 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12. Participants that were indeterminate at TOC/Day 12 or recurrent prior to Day 40 were excluded.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=13 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=10 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiological-ITT (mITT) Population
Recurrence -- Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiological-ITT (mITT) Population
Recurrence -- No
|
12 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 40 - Day 70Population: ME: Participants in the PP and Micro-ITT populations
Rate of late recurrence of CDI is defined as a new episode of diarrhea (≥ 3 unformed bowel movements \[Bristol Stool Scale score of 5, 6, or 7\] in a 24-hour period), with a positive toxin result and requires retreatment of CDI between Day 40 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between Day 40 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12. Participants that were indeterminate at TOC/Day 12 or recurrent prior to Day 40 were excluded.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=13 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=10 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiologically Evaluable (ME) Population
Recurrence -- Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Rate of Late Recurrence of Clostridioides Difficile Infection (Between Day 40 and Day 70) in the Microbiologically Evaluable (ME) Population
Recurrence -- No
|
12 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post TOC/Day 12 visit through Day 70Population: Micro-ITT: All participants in the ITT population who have C. difficile isolated in culture and who are C. difficile toxin positive at the central laboratory from a screening or Day 1 fecal sample
Rate of recurrence of CDI is defined as a new episode of diarrhea (≥3 unformed bowel movements \[Bristol Stool Scale score of 5, 6, or 7\] in a 24-hour period) with a positive toxin result and requires retreatment for CDI at any point between TOC/Day 12 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiological-ITT (mITT) Population
Recurrence -- Yes
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiological-ITT (mITT) Population
Recurrence -- No
|
12 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post TOC/Day 12 visit through Day 70Population: ME: Participants in the PP and Micro-ITT populations.
Rate of recurrence of CDI is defined as a new episode of diarrhea (≥3 unformed bowel movements \[Bristol Stool Scale score of 5, 6, or 7\] in a 24-hour period) with a positive toxin result and requires retreatment for CDI at any point between TOC/Day 12 and Day 70. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 70 and those that did not. Analysis populations for this assessment only includes participants that had an investigator assessment of clinical cure at TOC/Day 12.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiologic Evaluable (ME) Population
Recurrence -- Yes
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Rate of Recurrence of Clostridioides Difficile Infection Through Day 70 in the Microbiologic Evaluable (ME) Population
Recurrence -- No
|
12 Participants
|
12 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Post TOC/Day 12 visit through Day 40Population: mITT: Participants in the ITT population who have Cdiff isolated in culture and are Cdiff toxin positive from a screening or Day 1 fecal sample
Global cure is defined as a clinical cure at TOC/Day 12 without recurrence through Day 40. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 40 and those that did not.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=13 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Global Cure in the Microbiological-ITT (mITT) Population
Global cure -- Yes
|
12 Participants
|
13 Participants
|
10 Participants
|
|
Rate of Global Cure in the Microbiological-ITT (mITT) Population
Global Cure --No
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post TOC/Day 12 visit through Day 40Population: PP: Participants who receive at least 80% of the planned doses, receive no concomitant systemic antibiotics, prohibited probiotic or anti-diarrheal medication from randomization through TOC, and have an investigator assessment of clinical response at TOC; ME: Participants in the PP and Micro-ITT populations
Global cure is defined as a clinical cure at TOC/Day 12 without recurrence through Day 40. The table below shows the number of participants per cohort that experienced a recurrence between TOC/Day 12 and Day 40 and those that did not.
Outcome measures
| Measure |
CRS3123 200 Milligram
n=12 Participants
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=14 Participants
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=13 Participants
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Rate of Global Cure in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Global Cure -- No
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Rate of Global Cure in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
PP · Global Cure -- Yes
|
12 Participants
|
13 Participants
|
10 Participants
|
|
Rate of Global Cure in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Global Cure -- Yes
|
12 Participants
|
13 Participants
|
10 Participants
|
|
Rate of Global Cure in the Per Protocol (PP) and Microbiologically Evaluable (ME) Populations
ME · Global Cure -- No
|
0 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
CRS3123 200 Milligram
CRS3123 400 Milligram
Vancomycin 125 Milligram
Serious adverse events
| Measure |
CRS3123 200 Milligram
n=14 participants at risk
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=15 participants at risk
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=14 participants at risk
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/15 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
7.1%
1/14 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
Other adverse events
| Measure |
CRS3123 200 Milligram
n=14 participants at risk
CRS3123 200 milligram dose (400 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
CRS3123 400 Milligram
n=15 participants at risk
CRS3123 400 milligram dose (800 mg/day) given orally at approximately 12-hour intervals for 10 days.
|
Vancomycin 125 Milligram
n=14 participants at risk
Vancomycin 125 milligram dose (500 mg/day) given orally at approximately 6-hour intervals for 10 days.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/15 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
7.1%
1/14 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/15 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
21.4%
3/14 • Number of events 3 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14 • Number of events 2 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
6.7%
1/15 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
28.6%
4/14 • Number of events 4 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 2 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
6.7%
1/15 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/15 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
14.3%
2/14 • Number of events 2 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/15 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
20.0%
3/15 • Number of events 3 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
13.3%
2/15 • Number of events 2 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
0.00%
0/14 • Safety assessments were performed at each visit from screening/Day -1 to the final follow-up visit on Day 70
Adverse event information is reported by number and frequency per cohort by: 1) All-Cause Mortality: All anticipated and unanticipated deaths due to any cause, 2) Serious Adverse Events: All anticipated and unanticipated serious adverse events, grouped by organ system, and 3) Other Adverse Events: Anticipated and unanticipated events (not included in the serious adverse event table) that exceed a frequency threshold of 4% within any arm of the clinical study, grouped by organ system
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or other public disclosure, written or oral, relating to or derived from the Confidential Information, or relating to the Consultant's work with Crestone, shall be provided by the Consultant to Crestone at least 90 days prior to submission for publication or other disclosure. Crestone shall review the publication or other disclosure within a reasonable period of time and inform the Consultant as to whether or not Crestone consents to publication or other disclosure.
- Publication restrictions are in place
Restriction type: OTHER