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

NCT ID: NCT00150345

Last Updated: 2012-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-04-30

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.

Conditions

Possible Fungal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

voriconazole (Vfend)

Intervention Type: DRUG

voriconazole, early treatment

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.

Group Type: OTHER

voriconazole (Vfend)

Intervention Type: DRUG

voriconazole, deferred treatment

Interventions

voriconazole (Vfend)

voriconazole, early treatment

Intervention Type: DRUG

voriconazole (Vfend)

voriconazole, deferred treatment

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Oncology (DGHO)

UNKNOWN

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Augsburg, , Germany

Pfizer Investigational Site

Berlin, , Germany

Pfizer Investigational Site

Berlin, , Germany

Pfizer Investigational Site

Berlin, , Germany

Pfizer Investigational Site

Bielefeld, , Germany

Pfizer Investigational Site

Bremen, , Germany

Pfizer Investigational Site

Chemnitz, , Germany

Pfizer Investigational Site

Cologne, , Germany

Pfizer Investigational Site

Dresden, , Germany

Pfizer Investigational Site

Erlangen, , Germany

Pfizer Investigational Site

Essen, , Germany

Pfizer Investigational Site

Frankfurt (Oder), , Germany

Pfizer Investigational Site

Freiburg im Breisgau, , Germany

Pfizer Investigational Site

Göttingen, , Germany

Pfizer Investigational Site

Hanover, , Germany

Pfizer Investigational Site

Homburg/Saar, , Germany

Pfizer Investigational Site

Kiel, , Germany

Pfizer Investigational Site

Leipzig, , Germany

Pfizer Investigational Site

Ludwigshafen, , Germany

Pfizer Investigational Site

Lübeck, , Germany

Pfizer Investigational Site

Mainz, , Germany

Pfizer Investigational Site

München, , Germany

Pfizer Investigational Site

München, , Germany

Pfizer Investigational Site

Potsdam, , Germany

Pfizer Investigational Site

Stuttgart, , Germany

Pfizer Investigational Site

Trier, , Germany

Pfizer Investigational Site

Wiesbaden, , Germany

Pfizer Investigational Site

Würzburg, , Germany

Countries

Germany

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501029&StudyName=Immediate%20vs.%20Deferred%20Empirical%20Antifungal%20Treatment%20With%20Voriconazole%20In%20Neutropenic%20Patients

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Other Identifiers

A1501029

Identifier Type: -

Identifier Source: org_study_id