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

Last updated on November 12, 2019

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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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Descriptive Information
Brief Title  ICMJE Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
Official Title  ICMJE 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)
Brief Summary

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.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Possible Fungal Infection
Intervention  ICMJE
  • Drug: voriconazole (Vfend)
    voriconazole, early treatment
  • Drug: voriconazole (Vfend)
    voriconazole, deferred treatment
Study Arms  ICMJE
  • 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)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2010)
147
Original Enrollment  ICMJE
 (submitted: September 6, 2005)
200
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion DateApril 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150345
Other Study ID Numbers  ICMJE A1501029
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2012

ICMJE     Data element required by the

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

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