Possible Fungal Infection Clinical Trial
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)
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment