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

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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. Last updated on November 11, 2005. Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
Official 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
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.
Detailed Description	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.
Study Phase	Phase IV
Study Type ^†	Interventional
Study Design ^†	Prevention, Double-Blind
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Candidiasis
Intervention ^†	Drug: Fluconazole Drug: AmBisome
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	500
Start Date ^†
Completion Date	November 2005
Eligibility Criteria ^†	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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00001107
Organization ID	DMID 98-014
Secondary IDs ^††	MSG #44
Study Sponsor ^†	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^††
Investigators ^†
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	November 2005
First Received Date ^†	November 2, 1999
Last Updated Date	November 11, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.