NCT00841971

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 17, 2014

Completed
Last Updated

December 17, 2014

Status Verified

December 1, 2014

Enrollment Period

3.4 years

First QC Date

February 11, 2009

Results QC Date

December 8, 2014

Last Update Submit

December 15, 2014

Conditions

MycosesFungemiaCentral Nervous System Fungal InfectionsLung Diseases, Fungal

Outcome Measures

Primary Outcomes (1)

  • Frequency of Fungal Infection

    90 days post enrollment

Secondary Outcomes (1)

  • Need for Additional Antifungal Therapy

    90 days post enrollment

Study Arms (2)

anidulafungin

EXPERIMENTAL

anti-fungal agent

Drug: Anidulafungin

Fluconazole

ACTIVE COMPARATOR

anti-fungal agent

Drug: Fluconazole

Interventions

AnidulafunginDRUG

200 mg IV loading dose followed by 100 mg qd for 21 days

Also known as: Eraxis
anidulafungin
FluconazoleDRUG

400 mg IV for 21 days

Also known as: DIFLUCAN
Fluconazole

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA Medical Cente

Los Angeles, California, 90095, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Related Publications (2)

  • Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Singh N. Randomized, double-blind trial of anidulafungin versus fluconazole for prophylaxis of invasive fungal infections in high-risk liver transplant recipients. Am J Transplant. 2014 Dec;14(12):2758-64. doi: 10.1111/ajt.12963. Epub 2014 Nov 6.

    PMID: 25376267RESULT

  • Singh N, Winston DJ, Limaye AP, Pelletier S, Safdar N, Morris MI, Meneses K, Busuttil RW, Wagener MM, Wheat LJ. Performance Characteristics of Galactomannan and beta-d-Glucan in High-Risk Liver Transplant Recipients. Transplantation. 2015 Dec;99(12):2543-50. doi: 10.1097/TP.0000000000000763.

    PMID: 26050015DERIVED

MeSH Terms

Conditions

MycosesFungemiaCentral Nervous System Fungal InfectionsLung Diseases, Fungal

Interventions

AnidulafunginFluconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsInvasive Fungal InfectionsSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and ProteinsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr Nina Singh
Organization
University of Pittsburgh
nis5@pitt.edu
412 360-1688

Study Officials

  • Nina Singh, MD

    University of Pittaburgh, VA Pittsburgh Health Systems

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

February 1, 2010

Primary Completion

July 1, 2013

Study Completion

May 1, 2014

Last Updated

December 17, 2014

Results First Posted

December 17, 2014

Record last verified: 2014-12

Locations

US(6)