Trial Outcomes & Findings for Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients (NCT NCT00841971)

NCT ID: NCT00841971

Last Updated: 2014-12-17

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 200 participants
• Primary outcome timeframe: 90 days post enrollment
• Results posted on: 2014-12-17

Participant Flow

Participant milestones

Measure	Anidulafungin anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days	Fluconazole anti-fungal agent Fluconazole: 400 mg IV for 21 days
Overall Study STARTED	100	100
Overall Study COMPLETED	98	99
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients

Baseline characteristics by cohort

Measure	Anidulafungin n=100 Participants anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days	Fluconazole n=100 Participants anti-fungal agent Fluconazole: 400 mg IV for 21 days	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants	89 Participants n=7 Participants	178 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Age, Continuous	58 years n=5 Participants	58 years n=7 Participants	58 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	72 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	38 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	62 Participants n=7 Participants	135 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days post enrollment

Outcome measures

Measure	Anidulafungin n=98 Participants anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days	Fluconazole n=99 Participants anti-fungal agent Fluconazole: 400 mg IV for 21 days
Frequency of Fungal Infection	5 participants	8 participants

SECONDARY outcome

Timeframe: 90 days post enrollment

Outcome measures

Measure	Anidulafungin n=98 Participants anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days	Fluconazole n=99 Participants anti-fungal agent Fluconazole: 400 mg IV for 21 days
Need for Additional Antifungal Therapy	11 participants	11 participants

Adverse Events

Anidulafungin

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Fluconazole

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anidulafungin n=98 participants at risk anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days	Fluconazole n=99 participants at risk anti-fungal agent Fluconazole: 400 mg IV for 21 days
Cardiac disorders Prolonged QT interval	1.0% 1/98 • Number of events 1	0.00% 0/99

Other adverse events

Measure	Anidulafungin n=98 participants at risk anti-fungal agent Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days	Fluconazole n=99 participants at risk anti-fungal agent Fluconazole: 400 mg IV for 21 days
General disorders deaths	11.2% 11/98 • Number of events 11	11.1% 11/99 • Number of events 11

Additional Information

Dr Nina Singh

University of Pittsburgh

Phone: 412 360-1688

Email: nis5@pitt.edu

Results disclosure agreements

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