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NCT00001107 · ClinicalTrials.gov registry record · Phase 4
Comparison of Two Treatments to Prevent Invasive Fungal Infections in Patients Who Have Received Liver Transplants
A Phase 4 study of Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
- 1
- Study location
NCT00001107: Completed Phase 4 study of Candidiasis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001107 is a Phase 4 study of Candidiasis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 500 participants, above the 259-participant average among 7 other Candidiasis trials with a reported enrollment target (93% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001107, a Phase 4 study of Candidiasis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Fluconazole
- DRUG AmBisome
Study Locations (1)
Alabama
- Mary Ellen Bradley - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Est. Completion | 2005-11 |
| Phase | Phase 4 |
What the finished NCT00001107 record still lists
NCT00001107 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 259-participant average among 7 other Candidiasis trials with a reported enrollment target (93% higher).
The record links to 1 condition, with Candidiasis appearing as the primary indexed condition, and to 2 interventions - of which Fluconazole is the first listed.
NCT00001107 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT00001107 about?
NCT00001107 is a clinical study titled "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 t...
What is the current status of trial NCT00001107?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 500 participants. Estimated completion is 2005-11.
What conditions does trial NCT00001107 study?
This clinical trial studies the following conditions: Candidiasis.
What interventions are being tested in trial NCT00001107?
The interventions under investigation include: Fluconazole (DRUG), AmBisome (DRUG).
Who is sponsoring clinical trial NCT00001107?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001107 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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