Clinical trial NCT00150345: Immediate vs. Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Possible Fungal Infection
Keywords: Neutropenia
Fever of unknown origin
Empirical treatment
Voriconazole
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)
First posted: 2005-09-08
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Proven or Probable Invasive Fungal Infections (IFI): Complete Case Analysis
timeFrame: Day 2 through Day 28
Secondary outcomes:
measure: Number of Participants With Defervescence Day 5 (4 Days After Initiation of Study Treatment)
timeFrame: Day 5 (96 hours through 120 hours after start of study treatment)
measure: Number of Participants With Defervescence Day 9 (8 Days After Initiation of Study Treatment)
timeFrame: Day 9 (192 hours through 216 hours after start of study treatment)
measure: Time to Continuous Defervescence
timeFrame: Day 2 through Day 28
measure: Number of Participants Per Reason for Lack of Defervescence
timeFrame: Day 2 through Day 28
measure: Number of Participants That Died on or Before Day 28 (Mortality)
timeFrame: Day 2 through Day 28
measure: Time to Negative Panfungal Polymerase Chain Reaction (PCR)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (Yes)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association of Positive PCR Assessments With Achievement of Continuous Defervescence (No)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Age
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Gender
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Primary Underlying Neoplastic Disease
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Planned Allogeneic Transplants
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Concomitant Fluconazole
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Neutrophil Count >500 uL
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With C-reactive Protein Level >1.25 Times the Upper Limit of Normal (x ULN)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Fungal Species Identified (Aspergillus Spp=Yes)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Proven or Probable IFI (Complete Cases) Between Day 2 and Day 28
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence Day 5 (4 Days After Initiation of Study Treatment)
timeFrame: Day 5 (96 hours through 120 hours after start of study treatment)
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (Yes) by Day 9 (8 Days After Initiation of Study Treatment)
timeFrame: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Defervescence (No) by Day 9 (8 Days After Initiation of Study Treatment)
timeFrame: Day 2 through Day 9 (192 hours through 216 hours after start of study treatment)
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Time to Defervescence
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence (No)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Reasons for Lack of Continuous Defervescence: Unknown Infection (Yes)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Alive)
timeFrame: Day 2 through Day 28
measure: Course of Positive Panfungal PCR Assessments to Explanatory Variables: Association With Mortality by Day 28 (Died)
timeFrame: Day 2 through Day 28
measure: Number of Participants Assessed as Needing Further Antineoplastic Therapy as Planned
timeFrame: Day 28
measure: Number of Participants With Reasons Why Antineoplastic Therapy Not Continued as Planned
timeFrame: Day 28
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bielefeld
country: Germany
facility: Pfizer Investigational Site
city: Bremen
country: Germany
facility: Pfizer Investigational Site
city: Chemnitz
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt (Oder)
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Goettingen
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Homburg/Saar
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Luebeck
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Potsdam
country: Germany
facility: Pfizer Investigational Site
city: Stuttgart
country: Germany
facility: Pfizer Investigational Site
city: Trier
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: