At a glance
ClinicalIndex Comparison Record- ✓Acute leukemia, aggressive lymphoma, bone marrow or stem cell transplantation
- ✓Neutropenia (<500 neutrophils/µL) lasting at least 10 days
- ✓Newly diagnosed fever
- ✓Positive panfungal polymerase chain reaction assay
- ✕Documented bacterial infection during screening or at randomization
- ✕Fungemia or other documented invasive fungal infection during screening or at randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating voriconazole (Vfend) for Possible Fungal Infection. Completed, enrolled 147 participants across 28 sites.
Detailed 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.
Study Details
Timeline
Interventions
voriconazole, early treatment
voriconazole, deferred treatment