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NCT01519648 Clinical Trial

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

Invasive Fungal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01519648
Other study ID # RIFI
Secondary ID
Status Completed
Phase N/A
First received January 23, 2012
Last updated July 18, 2014
Start date January 2012
Est. completion date March 2014

Study information
Verified date July 2014
Source National Hematological Society, Russia
Contact n/a
Is FDA regulated No
Health authority Russia: Ministry of Health of the Russian Federation
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 808
Est. completion date March 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 95 Years
Eligibility Inclusion Criteria:

- Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy

- All newly allogeneic or autologous transplant recipients during the study period

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Russian Federation National Hematological Society Moscow

Sponsors (1)
Lead Sponsor Collaborator
National Hematological Society, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Rate of Invasive Fungal Infections 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. 6 month No
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