Trial Outcomes & Findings for A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections (NCT NCT02692651)
NCT ID: NCT02692651
Last Updated: 2022-03-25
Results Overview
Resolution of diarrhea defined as ≤ 3 unformed stools for 2 consecutive days maintained until the end of therapy and for 2 days afterwards. The treatment course was at least 10 days, but it could be extended to a maximum of 12 weeks.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
144 participants
Primary outcome timeframe
length of treatment plus 2 days, from a minimum of 12 to a maximum of 86 days
Results posted on
2022-03-25
Participant Flow
Participant milestones
| Measure |
Vancomycin
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Fidaxomicin
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
|---|---|---|
|
Study Treatment
STARTED
|
70
|
74
|
|
Study Treatment
COMPLETED
|
54
|
64
|
|
Study Treatment
NOT COMPLETED
|
16
|
10
|
|
Post Study Treatment Follow-up
STARTED
|
54
|
64
|
|
Post Study Treatment Follow-up
COMPLETED
|
50
|
60
|
|
Post Study Treatment Follow-up
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Vancomycin
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Fidaxomicin
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
|---|---|---|
|
Study Treatment
Death
|
7
|
3
|
|
Study Treatment
comfort care
|
1
|
1
|
|
Study Treatment
Protocol violation per treating team preference
|
8
|
6
|
|
Post Study Treatment Follow-up
Death
|
4
|
4
|
Baseline Characteristics
A Comparison of Fidaxomicin and Vancomycin in Patients With CDI Receiving Antibiotics for Concurrent Infections
Baseline characteristics by cohort
| Measure |
Fidaxomicin
n=74 Participants
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Vancomycin
n=70 Participants
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65
|
51 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Age, Customized
65-74
|
15 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Customized
>74
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
75 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
69 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
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 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
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
61 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
122 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
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
144 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
26.7 kg/m^2
n=99 Participants
|
28.2 kg/m^2
n=107 Participants
|
27.4 kg/m^2
n=206 Participants
|
|
Patients in ICU at enrollment
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
History of C difficile infection
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
History of cancer
|
34 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
History of stem cell transplant
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
History of inflammatory bowel disease
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
History of Proton Pump Inhibitors use
|
29 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
White blood cell count
|
9.46 1000 cells/μL
n=99 Participants
|
7.93 1000 cells/μL
n=107 Participants
|
8.7 1000 cells/μL
n=206 Participants
|
|
Creatinine
|
1.11 mg/dl
n=99 Participants
|
1.36 mg/dl
n=107 Participants
|
1.23 mg/dl
n=206 Participants
|
PRIMARY outcome
Timeframe: length of treatment plus 2 days, from a minimum of 12 to a maximum of 86 daysPopulation: Intention to treat analysis
Resolution of diarrhea defined as ≤ 3 unformed stools for 2 consecutive days maintained until the end of therapy and for 2 days afterwards. The treatment course was at least 10 days, but it could be extended to a maximum of 12 weeks.
Outcome measures
| Measure |
Fidaxomicin
n=74 Participants
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Vancomycin
n=70 Participants
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
|---|---|---|
|
Clinical Cure: Resolution of Diarrhea
|
54 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 30 days after treatment's end (maximum of 114 days)Population: Subjects who completed study treatment and were alive at the end of 30-day follow-up.
Recurrence is defined as all three of the following within 4 weeks after successfully completing study treatment: reappearance of symptoms of CDI (\>3 unformed stools in a 24 hour period; a positive stool PCR test for C. difficile; and the need for retreatment with an agent active against C. difficile).
Outcome measures
| Measure |
Fidaxomicin
n=60 Participants
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Vancomycin
n=50 Participants
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
|---|---|---|
|
Recurrence of CDI
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 40 to 114 daysPopulation: Subjects who completed the study treatment
Death in subjects who completed the study treatment and died within 30 days after end of treatment
Outcome measures
| Measure |
Fidaxomicin
n=64 Participants
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Vancomycin
n=54 Participants
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
|---|---|---|
|
30-day Mortality
|
4 Participants
|
4 Participants
|
Adverse Events
Fidaxomicin
Serious events: 11 serious events
Other events: 0 other events
Deaths: 7 deaths
Vancomycin
Serious events: 13 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Fidaxomicin
n=74 participants at risk
Fidaxomicin pill 200 mg PO 2 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
Vancomycin
n=70 participants at risk
Vancomycin solution 125 mg PO 4 times per day for 10 days or until the end of the duration of concomitant antibiotic exposure, whichever is longer.
|
|---|---|---|
|
Gastrointestinal disorders
Hospitalization
|
6.8%
5/74 • Number of events 5 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
2.9%
2/70 • Number of events 2 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
2.7%
2/74 • Number of events 3 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
5.7%
4/70 • Number of events 4 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
Infections and infestations
Hospitalization
|
0.00%
0/74 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
5.7%
4/70 • Number of events 4 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
Renal and urinary disorders
Hospitalization
|
1.4%
1/74 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
1.4%
1/70 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
Hepatobiliary disorders
Hospitalization
|
1.4%
1/74 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
1.4%
1/70 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
Nervous system disorders
Hospitalization
|
1.4%
1/74 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
2.9%
2/70 • Number of events 3 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
Skin and subcutaneous tissue disorders
Hospitalization
|
2.7%
2/74 • Number of events 2 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
1.4%
1/70 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
|
General disorders
Hospitalization
|
0.00%
0/74 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
1.4%
1/70 • Number of events 1 • Treatment period + 30 days, ranging from a total of 40 to 114 days.
Adverse events collected with follow-up surveys and by clinical alerts.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place