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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 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.

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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

FieldValue
Enrollment Target 500 participants
Est. Completion 2005-11
Phase Phase 4

What the Registry Record Tells You About NCT00001107

The ClinicalTrials.gov registry entry for NCT00001107 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 259-participant average among 7 other Candidiasis trials with a reported enrollment target (93% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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