NCT00001107

Brief Summary

The purpose of this study is to compare the safety and effectiveness of 2 treatments to prevent invasive fungal infections (IFI), which are infections caused by yeasts and molds that are common in patients with weak immune systems or transplant patients. AmBisome, a new treatment, will be compared to fluconazole, the traditional treatment for fungal infections caused by the yeast Candida. Treatment will only be given to liver transplant patients who are found to be at high risk for IFI. Liver transplant patients who are at low risk for IFI will be monitored but will receive no study medication. IFIs are found mainly in a high risk group of liver transplant patients, and are not common in those with low risk. If IFI preventive therapy is focused on the high risk group, there may be a lesser chance of Candida becoming resistant (able to grow despite the presence of drugs used to kill it). Treating only the high risk group will also save money.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 27, 2010

Status Verified

November 1, 2005

First QC Date

November 2, 1999

Last Update Submit

August 26, 2010

Conditions

Candidiasis

Interventions

FluconazoleDRUG
AmBisomeDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • You may be eligible for this study if you:
  • Have had a liver transplant within 5 days of enrollment and agree to receive tacrolimus.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Are HIV-positive.
  • Have a history of invasive fungal infection.
  • Have received antifungal agents within 14 days prior to your liver transplant.
  • Are allergic to azoles, amphotericin B, or tacrolimus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary Ellen Bradley

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Hadley S, Huckabee C, Pappas PG, Daly J, Rabkin J, Kauffman CA, Merion RM, Karchmer AW. Outcomes of antifungal prophylaxis in high-risk liver transplant recipients. Transpl Infect Dis. 2009 Feb;11(1):40-8. doi: 10.1111/j.1399-3062.2008.00361.x. Epub 2008 Dec 19.

    PMID: 19144094DERIVED

MeSH Terms

Conditions

Candidiasis

Interventions

Fluconazoleliposomal amphotericin B

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Completion

November 1, 2005

Last Updated

August 27, 2010

Record last verified: 2005-11

Locations

US(1)