Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-01-31 @ 2:40 AM
Study NCT ID:
NCT02451592
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2015-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fungemia in Hematologic Malignancies
Sponsor:
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
Organization:
Study Overview
Official Title:
SEIFEM 2015: Fungemia in Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this study is to determine the risk factors for fungemia in a population of patients diagnosed with hematologic malignancies and eligible for chemotherapy.
Detailed Description:
The coordinating center provides all participating centers with an epidemiologic form, in order to collect data in a comparable way. The requested informations include type of malignancy and its treatment, environmental expositions, laboratory work up, antifungal prophylaxis, clinical signs of infection, microbiological findings, antifungal therapy and outcome of infection at 30 days.
The planned sample size is about 300 patients to be recruited in 35 participating center over 5 years, in a retrospective-prospective fashion. Data check will be performed at the coordinating center. Missing data will be managed to minimize incomplete reports.
Statistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.
The planned sample size is about 300 patients to be recruited in 35 participating center over 5 years, in a retrospective-prospective fashion. Data check will be performed at the coordinating center. Missing data will be managed to minimize incomplete reports.
Statistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.
Study Oversight
Has Oversight DMC:
False
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?: