Trial Outcomes & Findings for Impact of Oral Antibiotic Treatment on C. Difficile (NCT NCT02057198)
NCT ID: NCT02057198
Last Updated: 2019-10-02
Results Overview
Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of \~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.
COMPLETED
PHASE4
33 participants
Days 0, 3, 7 and 14.
2019-10-02
Participant Flow
Participant milestones
| Measure |
Fidaxomicin
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Fidaxomicin
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Discharged early; lost to followup
|
0
|
1
|
0
|
Baseline Characteristics
Impact of Oral Antibiotic Treatment on C. Difficile
Baseline characteristics by cohort
| Measure |
Fidaxomicin
n=11 Participants
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=10 Participants
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=10 Participants
125 mg. orally 4 times a day for 10 days
Vancomycin
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 22 • n=99 Participants
|
62.2 years
STANDARD_DEVIATION 15.1 • n=107 Participants
|
63.4 years
STANDARD_DEVIATION 9.6 • n=206 Participants
|
62 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
31 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Days 0, 3, 7 and 14.Population: Only completed participants were included in the analysis.
Rodac plates were used to take environmental samples from 5 different sites within each patient's hospital room (bedrail, overbed table, sink, toilet seat, bathroom floor). Each Rodac plate samples a surface area of \~25 cm2. 5 replicates were taken for each site and repeated on days 0, 3, 7, and 14. Median total colony counts are reported for each treatment group. Data from the specified time points were combined to construct a decay slope, representing the reduction in log(CFUs)/day for each treatment group. We compared the slope (rate of change) between treatment groups using mixed effects models.
Outcome measures
| Measure |
Fidaxomicin
n=11 Participants
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=10 Participants
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=10 Participants
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.
Day 14
|
0 Colony forming units (CFUs)
Interval 0.0 to 0.0
|
0 Colony forming units (CFUs)
Interval 0.0 to 0.0
|
0 Colony forming units (CFUs)
Interval 0.0 to 0.0
|
|
Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.
Day 0
|
56 Colony forming units (CFUs)
Interval 0.0 to 158.0
|
33 Colony forming units (CFUs)
Interval 23.0 to 43.0
|
149 Colony forming units (CFUs)
Interval 0.0 to 227.0
|
|
Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.
Day 3
|
7 Colony forming units (CFUs)
Interval 4.0 to 9.0
|
53 Colony forming units (CFUs)
Interval 17.0 to 92.0
|
24 Colony forming units (CFUs)
Interval 5.0 to 43.0
|
|
Change in Total Median Total Colony Forming Units (CFU) of C. Difficile Identified in the Hospital Room Environment for Each Antibiotic Treatment Group.
Day 7
|
0 Colony forming units (CFUs)
Interval 0.0 to 0.0
|
15 Colony forming units (CFUs)
Interval 12.0 to 18.0
|
0 Colony forming units (CFUs)
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, and 14Population: Only completed participants were included in the analysis.
In addition to total colony counts over time, the investigators also assessed the proportion of positive cultures over time (from the 5 replicate Rodac plate samplings repeated at each of 5 sites within each patient room: bedrail, overbed table, sink, toilet seat and bathroom floor). The cumulative proportion of positive cultures (including days 0, 3, 7, 14) is reported according to each treatment group.
Outcome measures
| Measure |
Fidaxomicin
n=794 Environmental cultures
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=575 Environmental cultures
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=774 Environmental cultures
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Total Environmental Contamination According to Antibiotic Treatment Group
|
13.4 percentage of positive cultures
|
18.6 percentage of positive cultures
|
7.6 percentage of positive cultures
|
SECONDARY outcome
Timeframe: Days 0-14Population: Ribotyping could only be conducted in instances where sufficient growth occurred from both patient and environmental samples to permit subculture.
When sufficient growth was available to permit sub-culture and ribotyping, we conducted ribotyping of each patient's stool C. difficile isolate for comparison to isolates from the same patient's hospital environment. Reported is the total percent of hospital room environmental isolates that match the ribotyping of the associated patient's stool sample (there is no averaging).
Outcome measures
| Measure |
Fidaxomicin
n=22 Environmental Isolates
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=25 Environmental Isolates
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=9 Environmental Isolates
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Molecular Relatedness of Isolates
|
68.1 percent of matching isolates
|
80.0 percent of matching isolates
|
77.8 percent of matching isolates
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 14Population: Only completed participants were included in the analysis.
C. difficile was isolated and serially diluted to permit colony counts (CFU/g stool) over time for each patient.
Outcome measures
| Measure |
Fidaxomicin
n=11 Participants
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=10 Participants
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=10 Participants
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
C. Difficile Shedding in Stool Over Time
Day 0
|
815940 CFU/g stool
Standard Deviation 949503
|
2233564 CFU/g stool
Standard Deviation 3845558
|
35340 CFU/g stool
Standard Deviation 41612
|
|
C. Difficile Shedding in Stool Over Time
Day 3
|
72200 CFU/g stool
Standard Deviation 156429
|
1200 CFU/g stool
Standard Deviation 283
|
400 CFU/g stool
Standard Deviation 693
|
|
C. Difficile Shedding in Stool Over Time
Day 7
|
0 CFU/g stool
Standard Deviation 0
|
0 CFU/g stool
Standard Deviation 0
|
0 CFU/g stool
Standard Deviation 0
|
|
C. Difficile Shedding in Stool Over Time
Day 14
|
0 CFU/g stool
Standard Deviation 0
|
0 CFU/g stool
Standard Deviation 0
|
0 CFU/g stool
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 14Population: Only completed participants were included in the analysis.
Count of stool cultures positive for C. difficile at each time point
Outcome measures
| Measure |
Fidaxomicin
n=20 specimens
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=22 specimens
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=20 specimens
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Count of Stool Specimens From Patients That Are Positive for C. Difficile
Day 0
|
20 Number of positive stool cultures
|
21 Number of positive stool cultures
|
17 Number of positive stool cultures
|
|
Count of Stool Specimens From Patients That Are Positive for C. Difficile
Day 3
|
6 Number of positive stool cultures
|
3 Number of positive stool cultures
|
2 Number of positive stool cultures
|
|
Count of Stool Specimens From Patients That Are Positive for C. Difficile
Day 7
|
0 Number of positive stool cultures
|
0 Number of positive stool cultures
|
0 Number of positive stool cultures
|
|
Count of Stool Specimens From Patients That Are Positive for C. Difficile
Day 14
|
0 Number of positive stool cultures
|
0 Number of positive stool cultures
|
0 Number of positive stool cultures
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 14Population: Only completed participants were included in the analysis.
Percentage of stool cultures positive for C. difficile at each time point
Outcome measures
| Measure |
Fidaxomicin
n=20 specimens
200 mg. 2 times a day for 10 days
Fidaxomicin
|
Metronidazole
n=22 specimens
500 mg.orally 3 times daily for 10 days
Metronidazole
|
Vancomycin
n=20 specimens
125 mg. orally 4 times a day for 10 days
Vancomycin
|
|---|---|---|---|
|
Percentage of Stool Specimens From Patients That Are Positive for C. Difficile
Day 0
|
100 % of positive stool cultures
|
95.5 % of positive stool cultures
|
85 % of positive stool cultures
|
|
Percentage of Stool Specimens From Patients That Are Positive for C. Difficile
Day 3
|
60 % of positive stool cultures
|
75 % of positive stool cultures
|
33 % of positive stool cultures
|
|
Percentage of Stool Specimens From Patients That Are Positive for C. Difficile
Day 7
|
0 % of positive stool cultures
|
0 % of positive stool cultures
|
0 % of positive stool cultures
|
|
Percentage of Stool Specimens From Patients That Are Positive for C. Difficile
Day 14
|
0 % of positive stool cultures
|
0 % of positive stool cultures
|
0 % of positive stool cultures
|
Adverse Events
Fidaxomicin
Metronidazole
Vancomycin
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