Trial Outcomes & Findings for Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin (NCT NCT01818141)
NCT ID: NCT01818141
Last Updated: 2017-06-28
Results Overview
The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
day 10-13
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Fidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days
|
Vancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
16
|
|
Overall Study
COMPLETED
|
15
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Fidaxomicin
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days
|
Vancomycin
Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
No baseline C.diff colonies
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Study to Assess Inhibition of Spore Production in Patients With C. Difficile Infections: Fidaxomicin Versus Vancomycin
Baseline characteristics by cohort
| Measure |
Fidaxomicin
n=18 Participants
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days
|
Vancomycin
n=16 Participants
Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 15 • n=99 Participants
|
66 years
STANDARD_DEVIATION 15 • n=107 Participants
|
67 years
STANDARD_DEVIATION 15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
16 participants
n=107 Participants
|
34 participants
n=206 Participants
|
|
Baseline total colony forming units (CFU)
|
5.41 log10 CFU/g stool
STANDARD_DEVIATION 1.72 • n=99 Participants
|
4.96 log10 CFU/g stool
STANDARD_DEVIATION 1.81 • n=107 Participants
|
5.19 log10 CFU/g stool
STANDARD_DEVIATION 1.80 • n=206 Participants
|
|
Baseline spores CFU
|
5.00 log10 CFU/g stool
STANDARD_DEVIATION 1.44 • n=99 Participants
|
4.87 log10 CFU/g stool
STANDARD_DEVIATION 1.43 • n=107 Participants
|
4.94 log10 CFU/g stool
STANDARD_DEVIATION 1.47 • n=206 Participants
|
|
Baseline vegetative cells CFU
|
4.23 log10 CFU/g stool
STANDARD_DEVIATION 2.39 • n=99 Participants
|
4.22 log10 CFU/g stool
STANDARD_DEVIATION 2.1 • n=107 Participants
|
4.23 log10 CFU/g stool
STANDARD_DEVIATION 2.30 • n=206 Participants
|
PRIMARY outcome
Timeframe: day 10-13The number and percentage of patients who achieved at least 2 log10 colony forming units (CFU)/g of stool reductions of Clostridium difficile spores from baseline by the end of therapy (days 10-13).
Outcome measures
| Measure |
Vancomycin
n=9 Participants
Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days
|
Fidaxomicin
n=12 Participants
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days
|
|---|---|---|
|
C. Difficile Spore Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
|
6 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: day 10-13The number and percentage of patients who achieved at least 2 log10 CFU/g of stool reductions of Clostridium difficile vegetative cells from baseline by the end of therapy (days 10-13)
Outcome measures
| Measure |
Vancomycin
n=5 Participants
Vancomycin 125mg by mouth every 6 hours for 10 days
Vancomycin: Vancomycin 125mg by mouth every 6 hours for 10 days
|
Fidaxomicin
n=7 Participants
Fidaxomicin 200mg by mouth every 12 hours for 10 days
Fidaxomicin: Fidaxomicin 200mg by mouth every 12 hours for 10 days
|
|---|---|---|
|
C. Difficile Vegetative Cell Reduction of at Least 2 Log 10 Colony Forming Units (CFU)/g of Stool
|
5 Participants
|
4 Participants
|
Adverse Events
Fidaxomicin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vancomycin
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
Dr. David P. Nicolau, PharmD, FCCP, FIDSA
Hartford Hospital
Phone: 860-972-3941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place