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Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044486
Recruitment Status : Completed
First Posted : September 4, 2002
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

This trial is in high risk patients to determine the safety and efficacy of posaconazole vs. fluconazole in the prophylaxis against development of invasive fungal infections.

Profound, prolonged neutropenia (Absolute neutrophil count<500 cells/cubic mm for at least 7 days) due to induction chemotherapy for acute myelogenous leukemia, or myelodysplastic syndrome.

Treatment Duration: maximum of 12 weeks Follow-Up 2 months. Endpoints: incidence of proven or probable IFI according to EORTC/MSG criteria within the neutropenic episode and within 100 days of randomization as determined by external expert review.

Condition or disease Intervention/treatment Phase
Leukemia, Myelocytic, Acute Myelodysplastic Syndromes Neutropenia Drug: Posaconazole oral suspension Phase 3

Detailed Description:
This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis if IFI in high-risk subjects with prolonged profound neutropenia. The primary objective is to assess the efficacy of SCH 56592 vs fluconazole and itraconazole in preventing proven or probable IFI during neutropenic episodes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 602 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Posaconazole (SCH 56592) vs. Standard Azole Therapy for the Prevention of Invasive Fungal Infections Among High-Risk Neutropenic Patients
Study Start Date : July 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : April 2005

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults or adolescents (age>13 years) and weight> 34kg, either gender
  • Disease definition: Anticipated or documented prolonged neutropenia (ANC<500/mm3 2) Eastern Cooperative Oncology Group (ECOG) performance score of less than 3.
  • Female subjects of childbearing age must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation).
  • Female subjects of childbearing potential must have a negative serum pregnancy test (beta-hcG) at Baseline or within 72 hours before the start of the study drug.

Exclusion Criteria:

  • Female subjects who are pregnant, intend to become pregnant, or are nursing.
  • Excluded prior treatments: Subjects previously treated with AMB, FLZ, or ITZ for proven or probable IFI within 30 days of enrollment.
  • Excluded treatments prior to specific study phases: Subjects who have taken the following drugs: those known to interact with azoles and that may lead to life-threatening side effects.
  • Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.
  • Subjects who are participating in any other blinded clinical study within 30 days of study entry.
  • Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at Baseline or likely to require dialysis during the study).
  • Subjects having an ECG with a prolonged QTc interval by manual reading: QTc greater than 450 msec for men and greater than 470 msec for women.
  • Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00044486    
Other Study ID Numbers: P01899
First Posted: September 4, 2002    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Merck Sharp & Dohme Corp.:
fungal infections
Acute Myelogenous Leukemia
Anticipated prolonged profound neutropenia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Leukocyte Disorders
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs