A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation

Completed

• Conditions: Invasive Fungal Infections

• Registration Number: NCT01519648
• Lead Sponsor: National Hematological Society, Russia

Brief Summary

Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

Detailed Description

This multi-center observational study of IFI in high risk hematological patients, the study will investigate the epidemiology of IFI, describe antifungal strategy, proportion of antifungal prophylaxis, empiric therapy, pre-emptive therapy and targeted therapy in at-risk patients.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-26
• Study First Posted: 2012-01-27
• Primary Completion: 2013-09
• Study Completion: 2014-03
• Results First Submitted: 2014-06-18
• Results First Submitted QC: 2014-06-18
• Status Verified: 2014-07
• Results First Posted: 2014-07-18
• Last Update Submitted: 2014-07-18
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 808

Inclusion Criteria

• Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
• All newly allogeneic or autologous transplant recipients during the study period

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Rate of Invasive Fungal Infections	6 month	Estimate the rate of IFIs in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.

Trial Locations

Locations (1)

National Hematological Society; 🇷🇺 Moscow, Russian Federation