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Completed

NCT Number: NCT00001107

Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants

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.

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Infections Mycoses

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mary Ellen Bradley

Birmingham, Alabama, 35294, United States

About this study

If you are in the high risk group you will be assigned randomly (like tossing a coin) to receive either AmBisome or fluconazole. If you are in the low risk group, you will not receive any treatment. Both groups will be monitored for IFIs. The study will last for 100 days following your liver transplant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

You may be eligible for this study if you:

  • Have had a liver transplant within 5 days of enrollment and agree to receive tacrolimus.

Exclusion criteria

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.

Treatment and study plan

Fluconazole

Drug

AmBisome

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Official study title

Invasive Fungal Infection in Liver Transplant Recipients: A Randomized Double-Blind Trial Comparing AmBisome and Fluconazole in the High Risk Group and an Observational Cohort Study in the Low Risk

Important dates

Study completion
2005
First posted
Aug 31, 2001
Registry last updated
Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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