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Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In High-Risk Neutropenic Patients With Fever And A Positive Panfungal Polymerase Chain Reaction Assay (IDEA Study)


Phase 3
18 Years
N/A
Not Enrolling
Both
Possible Fungal Infection

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Trial Information

Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In High-Risk Neutropenic Patients With Fever And A Positive Panfungal Polymerase Chain Reaction Assay (IDEA Study)


Inclusion Criteria:



- Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;

- Neutropenia (<500 neutrophils/┬ÁL) of at least 10 days;

- Newly diagnosed fever;

- Positive panfungal polymerase chain reaction assay

Exclusion Criteria:

- Documented bacterial infection during screening or at randomization

- Fungemia or other documented invasive fungal infection during screening or at
randomization.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis

Outcome Description:

Number of participants with proven (deep tissue infection, fungemia, or endemic fungal infections) or probable IFI (at least 1 host criterion [fever, body temperature <36 or >38 degrees Celsius, graft-versus-host disease, use of corticosteroids]; and 1 microbiological criterion [fungal or yeasts]; or clinical criteria [abnormal site consistent with infection]) as defined by European Organization for Research and Treatment of Cancer Mycosis Study Group (EORTC/MSG) criteria. Complete case analysis: must be evaluable until Day 28 or had developed a proven or probable IFI by the final visit.

Outcome Time Frame:

Day 2 through Day 28

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

A1501029

NCT ID:

NCT00150345

Start Date:

January 2005

Completion Date:

April 2009

Related Keywords:

  • Possible Fungal Infection
  • Neutropenia
  • Fever of unknown origin
  • Empirical treatment
  • Voriconazole
  • Mycoses

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