NCT00044486

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2002

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2002

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 4, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

2.4 years

First QC Date

August 29, 2002

Last Update Submit

March 7, 2017

Conditions

Leukemia, Myelocytic, AcuteMyelodysplastic SyndromesNeutropenia

Keywords

ProphylaxisneutropeniaAMLMDSfungal infectionsAcute Myelogenous LeukemiaAnticipated prolonged profound neutropenia

Interventions

Posaconazole oral suspensionDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cornely OA, Maertens J, Winston DJ, Perfect J, Ullmann AJ, Walsh TJ, Helfgott D, Holowiecki J, Stockelberg D, Goh YT, Petrini M, Hardalo C, Suresh R, Angulo-Gonzalez D. Posaconazole vs. fluconazole or itraconazole prophylaxis in patients with neutropenia. N Engl J Med. 2007 Jan 25;356(4):348-59. doi: 10.1056/NEJMoa061094.

    PMID: 17251531DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesNeutropeniaMycoses

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersBacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2002

First Posted

September 4, 2002

Study Start

July 1, 2002

Primary Completion

December 1, 2004

Study Completion

April 1, 2005

Last Updated

March 10, 2017

Record last verified: 2017-03