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| Sponsor: | University of Cologne |
|---|---|
| Information provided by: | University of Cologne |
| ClinicalTrials.gov Identifier: | NCT00152594 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myelocytic, Acute |
Drug: voriconazole |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | 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 |
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | January 2006 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:
Contacts and Locations| Germany | |
| Johann Wolfgang Goethe-Universität Frankfurt am Main | |
| Frankfurt am Main, Germany, 60590 | |
| Universitätsklinikum Mannheim, Universität Heidelberg | |
| Heidelberg, Germany, 68305 | |
| Klinikum der Universität Köln | |
| Köln, Germany, 50931 | |
| Principal Investigator: | Oliver A. Cornely, MD | Klinikum der Universität Köln |
More Information
| ClinicalTrials.gov Identifier: | NCT00152594 History of Changes |
| Other Study ID Numbers: | NRA 150 0009 |
| Study First Received: | September 7, 2005 |
| Last Updated: | November 13, 2006 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Voriconazole Antifungal Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |