Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190463
Status:
TERMINATED
Last Update Posted:
2006-09-21
First Post:
2005-09-15
Brief Title:
Comparison of 2 Antifungal Treatment Empirical Versus Pre-Empirical Strategies in Prolonged Neutropenia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
The Strategy Antifungal Empirical Traditional is Again Justified in Prolonged Neutropenias Study PREVERT
Status:
TERMINATED
Status Verified Date:
2006-09
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:
None
Brief Summary:
Empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics The rational is that fungal infections are difficult to early diagnose and are life-threatening Historical trials have shown a small benefit of survival when this strategy is used According to the drug usde for this strategy safety and costs may be concerns However since this routine practice has been implemented in hematology new non-invasive biological diagnostic methods are available to early diagnose fungal infections such as galactomannan antigenemia for aspergillosis The goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies
Detailed Description:
Patients are eligible if they have an hematologic malignancy and receive chemotherapy with an expected neutropenic phase of 10 days Patients are randomized according to a 11 ratio to receive either the usual empirical strategy antifungals are introduced if they have persistent fever after 4 days of broad-spectrum antibacterials or the pre-empirical strategy administration of antifungals is limited to patients with pneumonia septic shock sinusitis grade 3 mucositis aspergillus colonization liver or splenic abscesses or positive galactomannan antigenemia The antifungals administered are deoxycholate amphotericin B or liposome amphotericin B according to the creatinin clearance This strategy is applied during the first 14 days of persistent fever then the therapy is left at the discretion of the investigator The primary endpoint is survival at neutrophil recovery or in case of persistent neutropenia at day 60 at the latest Secondary objectives are the incidence of invasive fungal infections IFI IFI-free survival number of febrile days and renal function at study completion
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOR02028 | None | None | None |