Clinical Trials Directory

Trials / Terminated

TerminatedNCT00152594

Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia

Phase III Study of Safety, Tolerance, Efficacy, Pharmacokinetics, and Costs of Therapy With Voriconazole or Placebo in the Prophylaxis of Lung Infiltrates in Patients Undergoing Induction Chemotherapy for Acute Myelogenous Leukemia

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
150 (planned)
Sponsor
University of Cologne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to determine whether voriconazole is as effective as antifungal prophylaxis in patients undergoing chemotherapy for acute myelogenous leukemia (AML). Hypothesis: Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after the start of induction chemotherapy.

Conditions

Interventions

TypeNameDescription
DRUGvoriconazole

Timeline

Start date
2004-10-01
Completion
2006-01-01
First posted
2005-09-09
Last updated
2006-11-14

Locations

3 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT00152594. Inclusion in this directory is not an endorsement.