Trial Outcomes & Findings for Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients (NCT NCT02200328)
NCT ID: NCT02200328
Last Updated: 2017-05-17
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
76 participants
Primary outcome timeframe
30 days
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
Metronidazole
Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
|
Placebo
Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
33
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
33
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Baseline characteristics by cohort
| Measure |
Metronidazole
n=43 Participants
Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
|
Placebo
n=33 Participants
Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71 years
n=5 Participants
|
71.8 years
n=7 Participants
|
71.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 participants
n=5 Participants
|
33 participants
n=7 Participants
|
76 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysPopulation: 0 participants were analyzed due to large number of patients not complying to the instructions and loss to follow up.
Outcome measures
Outcome data not reported
Adverse Events
Metronidazole
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place