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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Possible Fungal Infection

Treatments: Drug: voriconazole (Vfend)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00150345

A1501029

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 2 patient groups

Early treatment

Experimental group

Description:

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.

Treatment:

Drug: voriconazole (Vfend)

Deferred treatment

Other group

Description:

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.

Treatment:

Drug: voriconazole (Vfend)