Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150345
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2005-09-06
Brief Title:
Immediate vs Deferred Empirical Antifungal Treatment With Voriconazole In Neutropenic Patients
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDEA
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None