Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001107
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
1999-11-02
Brief Title:
Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MSG 44 | None | None | None |