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

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ClinicalTrials.gov Identifier: NCT00152594
Recruitment Status : Terminated
First Posted : September 9, 2005
Last Update Posted : November 14, 2006
Sponsor:
Information provided by:
University of Cologne

September 7, 2005
September 9, 2005
November 14, 2006
October 2004
Not Provided
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo
To determine the incidence of lung infiltrates until day 21 among patients undergoing the first induction chemotherapy for acute myelogenous leukemia who are randomized to prophylactic voriconazole or placebo.
Complete list of historical versions of study NCT00152594 on ClinicalTrials.gov Archive Site
  • To determine and compare between study arms the: incidence of fever and other signs of infection
  • incidence and type of documented bacteremia
  • rate of patients with systemic open-label antifungal therapy
  • time to initiation of systemic open-label antifungal therapy
  • duration of absolute neutrophil count < 500/µl
  • rate and type of proven, probable and possible breakthrough invasive fungal infections
  • rate of patients with fever of unknown origin
  • incidence and severity of adverse events
  • trough voriconazole plasma level after day 8 of study treatment
  • direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
  • overall costs in terms of the diagnosis related groups applied to the study patients
  • To determine and compare between study arms the
  • 1. incidence of fever and other signs of infection
  • 2. incidence and type of documented bacteremia
  • 3. rate of patients with systemic open-label antifungal therapy
  • 4. time to initiation of systemic open-label antifungal therapy
  • 5. duration of absolute neutrophil count <500/µl
  • 6. rate and type of proven, probable and possible breakthrough invasive fungal infections
  • 7. rate of patients with fever of unknown origin
  • 8. incidence and severity of adverse events
  • 9. trough voriconazole plasma level after day 8 of study treatment
  • 10. Direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
  • 11. overall costs in terms of the diagnosis related groups applied to the study patients
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Leukemia, Myelocytic, Acute
Drug: voriconazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
150
Same as current
January 2006
Not Provided

Inclusion Criteria:

  1. Newly diagnosed or relapsed, de novo or secondary AML
  2. First induction chemotherapy cycle
  3. Expected neutropenic phase of a minimum duration of 10 days
  4. Age >= 18 years
  5. Legally signed consent form

Exclusion Criteria:

  1. Known proven, probable or possible invasive fungal infection at randomization or in patient history
  2. Computed tomography (CT) with any signs of a fungal infection according to the European Organisation for the Research and Treatment of Cancer (EORTC)/Mycosis Study Group (MSG) criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
  3. Any current fever unless explained by non-infectious causes
  4. Antibacterial prophylaxis other than TMP/SMX
  5. Liver function test [LFT] (AST/ALT/bilirubin) more than 3x the upper normal limit
  6. Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:

    • Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine);
    • Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulfonylureas, ergot alkaloids, sirolimus, vinca alkaloids).
  7. Subjects who have received the following drugs within 14 days prior to randomization: potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
  8. Concomitant therapy with absorbable antifungals
  9. Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
  10. Known hypersensitivity or other contraindication to voriconazole
  11. Patient is unwilling or unable to comply with the protocol.
  12. Diseases or disabilities preventing the patient from participating in the trial
  13. Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00152594
NRA 150 0009
Not Provided
Not Provided
Not Provided
Not Provided
University of Cologne
Not Provided
Principal Investigator: Oliver A. Cornely, MD Klinikum der Universität Köln
University of Cologne
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP