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Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Augsburg, , 86156 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Possible Fungal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- Neutropenia (

- Newly diagnosed fever;

- Positive panfungal polymerase chain reaction assay

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Documented bacterial infection during screening or at randomization

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

NCT00150345
Pfizer
Completed
Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients

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Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
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)

A well-known side-effect of cytostatics (drugs against malignancies) is a decrease in the number of white blood cells, especially of the so-called neutrophil granulocytes, which are very important for the defense against infections. Hence their decrease (called "neutropenia") leads to a predisposition to infections.

Since infections during neutropenia can be very dangerous, the patients are treated with antibiotics from the very first signs of such an infection (usually fever). If the antibiotics (drugs against bacteria) do not lead to a normalization of the body temperature within four days, a drug against fungi is added.

In the IDEA study, one half of the patients receive the antifungal drug voriconazole (as usual) only in case the antibiotics alone do not lead to a normalization of the body temperature (current standard of care). The other half of the patients receive voriconazole immediately after onset of fever (concomitantly with the antibiotics).

The research question is, whether in the "early-treatment" group fewer manifest fungal infections will be observed than in the "late-treatment" group.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Possible Fungal Infection
  • Drug: voriconazole (Vfend)
    voriconazole, early treatment
  • Drug: voriconazole (Vfend)
    voriconazole, deferred treatment
  • Experimental: Early treatment
    Voriconazole starts within 18 hours of onset of fever intravenously with a loading dose of 6 mg/kg q12h for the first two doses followed by 4 mg/kg q12h (maintenance dose). Switched to oral treatment (200 mg BID) is possible after at least four days. Treatment will be ended if the patient is afebrile (< 38.0 °C) for 7 days with neutrophil counts < 500/µL, or if the patient is afebrile (< 38.0 °C) for 2 days with neutrophil counts > 500/µL.
    Intervention: Drug: voriconazole (Vfend)
  • Deferred treatment
    Treatment with voriconazole (for dosage see "early treatment arm") is initiated only if a patient is persistently febrile on day 5 after the onset of fever despite antibiotic treatment.
    Intervention: Drug: voriconazole (Vfend)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
147
April 2009
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation;
  • Neutropenia (<500 neutrophils/µL) 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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00150345
A1501029
No
Not Provided
Not Provided
Pfizer
Pfizer
Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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