Trial Outcomes & Findings for PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol (NCT NCT03617172)
NCT ID: NCT03617172
Last Updated: 2022-11-30
Results Overview
Number of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
8 weeks
Results posted on
2022-11-30
Participant Flow
Due to low enrollment the study was closed early.
Participant milestones
| Measure |
Study Drug (Misoprostol)
Misoprostol 100Mcg Tab: Two 100mcg capsules twice per day
|
Placebo
Placebo: Two capsules twice per day
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Study Drug (Misoprostol)
Misoprostol 100Mcg Tab: Two 100mcg capsules twice per day
|
Placebo
Placebo: Two capsules twice per day
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
Baseline characteristics by cohort
| Measure |
Study Drug (Misoprostol)
n=3 Participants
Misoprostol 100Mcg Tab: Two 100mcg capsules twice per day
|
Placebo
n=3 Participants
Placebo: Two capsules twice per day
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksNumber of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.
Outcome measures
| Measure |
Study Drug (Misoprostol)
n=2 Participants
Misoprostol 100Mcg Tab: Two 100mcg capsules twice per day
|
Placebo
n=3 Participants
Placebo: Two capsules twice per day
|
|---|---|---|
|
Number of Participants With Clinical Recurrence of Clostridium Difficile Infection (CDI).
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksNumber of recurrences during the follow-up period (for those who have a first recurrence during the follow-up time period)
Outcome measures
| Measure |
Study Drug (Misoprostol)
n=2 Participants
Misoprostol 100Mcg Tab: Two 100mcg capsules twice per day
|
Placebo
n=3 Participants
Placebo: Two capsules twice per day
|
|---|---|---|
|
Number of Recurrences During the Follow-up Period
|
0 number of events
|
0 number of events
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: These data were not collected because no participants experienced recurrence.
Time to resolution of diarrhea (TTROD; for those with recurrence)
Outcome measures
Outcome data not reported
Adverse Events
Study Drug (Misoprostol)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Clinical Trials Operations Manager
Vanderbilt University Medical Center
Phone: 6159360815
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place