Immediate vs Deferred Empirical Antifungal Treatment With Voriconazole in Neutropenic Patients

Condition(s) targeted: Neutropenia

Intervention: Voriconazole (Drug); Voriconazole (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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 defence 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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: To show whether initiation of voriconazole treatment immediately after onset of fever leads to a lower rate of probable and proven invasive fungal infections as compared to a strategy with initiation of voriconazole treatment only.

Secondary outcome:

Time to negative panfungal PCR

Rate of defervescence 96 hours after initiation of study treatment

Rate of defervescence 192 hours after initiation of study treatment

Time to defervescence and reasons for lack of defeverescence

Mortality on day 28 after randomization

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Bielefeld 33611, Germany; Recruiting

Pfizer Investigational Site, Koeln 50937, Germany; Recruiting

Pfizer Investigational Site, Goettingen 37075, Germany; Recruiting

Pfizer Investigational Site, Berlin 10117, Germany; Recruiting

Pfizer Investigational Site, Muenchen 81675, Germany; Recruiting

Pfizer Investigational Site, Erlangen 91054, Germany; Recruiting

Pfizer Investigational Site, Idar-Oberstein 55743, Germany; Not yet recruiting

Pfizer Investigational Site, Homburg/Saar 66421, Germany; Recruiting

Pfizer Investigational Site, Luebeck 23538, Germany; Recruiting

Pfizer Investigational Site, Wiesbaden 65191, Germany; Recruiting

Pfizer Investigational Site, Freiburg 79106, Germany; Recruiting

Pfizer Investigational Site, Chemnitz 09113, Germany; Recruiting

Pfizer Investigational Site, Leipzig 04103, Germany; Recruiting

Pfizer Investigational Site, Hannover 30623, Germany; Recruiting

Pfizer Investigational Site, Augsburg 86156, Germany; Recruiting

Pfizer Investigational Site, Ludwigshafen 67063, Germany; Recruiting

Pfizer Investigational Site, Dresden 01307, Germany; Recruiting

Pfizer Investigational Site, Berlin 12200, Germany; Recruiting

Pfizer Investigational Site, Essen 45239, Germany; Recruiting

Pfizer Investigational Site, Trier 54290, Germany; Recruiting

Pfizer Investigational Site, Stuttgart 70376, Germany; Recruiting

Pfizer Investigational Site, Wuerzburg 97070, Germany; Recruiting

Pfizer Investigational Site, Berlin 13353, Germany; Recruiting

Pfizer Investigational Site, Kiel 24116, Germany; Recruiting

Pfizer Investigational Site, Potsdam 14467, Germany; Recruiting

Pfizer Investigational Site, Mainz 55101, Germany; Recruiting

Pfizer Investigational Site, Frankfurt (Oder) 15236, Germany; Recruiting

Pfizer Investigational Site, Bremen 28177, Germany; Recruiting

Pfizer Investigational Site, Muenchen 81737, Germany; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: January 2005
Ending date: March 2009
Last updated: February 11, 2009