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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Nina Singh, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00841971

First received: February 11, 2009

Last updated: November 14, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 11, 2009

Last Updated Date

November 14, 2011

Start Date ^ICMJE

February 2010

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of fungal infection [ Time Frame: 90 days post enrollment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841971 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Need for additional antifungal therapy [ Time Frame: 90 days post enrollment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

Brief Summary

The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

Detailed Description

A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.

Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.

Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.

Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.

The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Mycoses
Fungemia
Central Nervous System Fungal Infections
Lung Diseases, Fungal

Intervention ^ICMJE

Drug: Anidulafungin
200 mg IV loading dose followed by 100 mg qd for 21 days
Drug: Fluconazole
400 mg IV for 21 days

Other Name: DIFLUCAN

Study Arm (s)

Experimental: anidula
Intervention: Drug: Anidulafungin
Active Comparator: Flu
anti-fungal agent

Intervention: Drug: Fluconazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Liver transplant recipient at increased risk for infection increased risk include any of the following:
retransplantation
renal replacement therapy (dialysis),
post transplant abdominal surgery (within 21days)
receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding transplant
ICU care for greater than 48 hours at the time of transplantation
colonization with Candida sps within 4 weeks of transplantation
requirement of 15 units or greater of packed red cell transfusions
Intraoperative time exceeding 6 hours

Exclusion Criteria:

Hypersensitivity to azole or echinocandin antifungal agents
receipt of systemic antifungal therapy within 4 weeks prior to transplantation

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00841971

Other Study ID Numbers ^ICMJE

PRO08110001

Has Data Monitoring Committee

Yes

Responsible Party

Nina Singh, University of Pittsburgh

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nina Singh, MD

University of Pittaburgh, VA Pittsburgh Health Systems

Information Provided By

University of Pittsburgh

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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