A Phase 4 interventional study of Fluconazole and AmBisome in Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2010-08-27.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 4, Interventional, and Prevention
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.
270 studies on the registry are indexed under Candidiasis; 20 are open to participants now.
This study's enrollment of 500 is above the median of 99 across 191 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,445 studies on the registry; 182 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 300 (75%) have results posted.
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This study is completed, as verified in Nov 2005. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluconazole · Liposomal amphotericin B
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