Trial Outcomes & Findings for Efficacy of 30-day Duration of Fidaxomicin for Recurrent C. Difficile Infection (NCT NCT02395848)

NCT ID: NCT02395848

Last Updated: 2023-03-24

Results Overview

clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well through study day 30.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 31 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2023-03-24

Participant Flow

Participant milestones

Measure	Fidaxomicin 30-day fidaxomicin (200mg twice daily x 10 days followed by 200mg once daily x 20 days)
Overall Study STARTED	31
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Fidaxomicin 30-day fidaxomicin (200mg twice daily x 10 days followed by 200mg once daily x 20 days)
Overall Study Lost to Follow-up	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fidaxomicin n=31 Participants 30-day fidaxomicin
Age, Categorical <=18 years	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=31 Participants
Age, Categorical >=65 years	20 Participants n=31 Participants
Sex: Female, Male Female	23 Participants n=31 Participants
Sex: Female, Male Male	8 Participants n=31 Participants
Region of Enrollment Canada	31 participants n=31 Participants

PRIMARY outcome

Timeframe: 30 days

clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well through study day 30.

Outcome measures

Measure	Fidaxomicin n=29 Participants 30-day fidaxomicin
Clinical Response at 30-day Completion of Fidaxomicin	24 Participants

PRIMARY outcome

Timeframe: 8 week following completion of fidaxomicin

sustained clinical response will be defined as those participants who have improvement in the number of bowel movements as determined by ≤ 3 unformed stools in a 24-hour period for 2 consecutive days during treatment and remaining well 8 weeks following completion of fidaxomicin

Outcome measures

Measure	Fidaxomicin n=29 Participants 30-day fidaxomicin
Sustained Clinical Response 8 Weeks Following Completion of 30-day Course of Fidaxomicin	22 Participants

PRIMARY outcome

Timeframe: Up to 8 weeks following completion of fidaxomicin

patients not meeting the definition of cure and requiring additional antibiotics for current CDI episode

Outcome measures

Measure	Fidaxomicin n=29 Participants 30-day fidaxomicin
Treatment Failure	7 Participants

Adverse Events

Fidaxomicin

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fidaxomicin n=29 participants at risk 30-day fidaxomicin
Gastrointestinal disorders Clostridium difficile infection	3.4% 1/29 • Number of events 1 • Up to 8 weeks from the last dose of fidaxomicin; 12 weeks from enrollment into the study
Renal and urinary disorders Electrolyte disorder and uremia in a patient with pre-existing renal failure on chronic hemodialysis	3.4% 1/29 • Number of events 1 • Up to 8 weeks from the last dose of fidaxomicin; 12 weeks from enrollment into the study

Other adverse events

Measure	Fidaxomicin n=29 participants at risk 30-day fidaxomicin
Gastrointestinal disorders Diarrhea	24.1% 7/29 • Number of events 7 • Up to 8 weeks from the last dose of fidaxomicin; 12 weeks from enrollment into the study

Additional Information

Christine Lee

McMaster University

Phone: 2505191898

Email: clee@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place