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Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
This study has been completed.
Study NCT00001107   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)
First Received: November 2, 1999   Last Updated: November 11, 2005   History of Changes

November 2, 1999
November 11, 2005
 
 
 
 
Complete list of historical versions of study NCT00001107 on ClinicalTrials.gov Archive Site
 
 
 
Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
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

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.

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.

Phase IV
Interventional
Prevention, Double-Blind
Candidiasis
  • Drug: Fluconazole
  • Drug: AmBisome
 
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. Epub 2008 Dec 19.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
500
November 2005
 

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001107
 
DMID 98-014, MSG #44
National Institute of Allergy and Infectious Diseases (NIAID)
 
 
National Institute of Allergy and Infectious Diseases (NIAID)
November 2005

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