MedTrace Logo

Liposomal Amphotericin B (Ambisome) Versus Oral Voriconazole for the Prevention of Invasive Fungal Infections

NCT00418951 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-08-07

Study results available
· View outcomes & findings →

Summary

The goal of this clinical research study is to compare the effectiveness of liposomal amphotericin B given three times per week , versus liposomal amphotericin B given once per week, versus oral voriconazole in the prevention of fungal infections in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes MDS who are receiving chemotherapy. The safety of these treatments will also be studied and compared.

Conditions

Interventions

DRUG

Voriconazole

400 mg by mouth twice daily on day 1, followed by 200 mg by mouth twice daily

DRUG

Liposomal amphotericin B

3 mg/kg intravenously three times per week over 2 hours +/- 15 minutes

DRUG

Liposomal amphotericin B

9 mg/kg intravenously once per week over 2 hours +/- 15 minutes

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Gloria N Mattiuzzi, MD · M.D. Anderson Cancer Center

  • Gloria N Mattiuzzi, MD · The University of Texas MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418951 on ClinicalTrials.gov