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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519648
First Posted: January 27, 2012
Last Update Posted: July 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Hematological Society, Russia
  Purpose
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.

Condition
Invasive Fungal Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Russian Prospective Observational Study of Invasive Fungal Infections in Patients With Acute Leukemia and Hematopoietic Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by National Hematological Society, Russia:

Primary Outcome Measures:
  • The Rate of Invasive Fungal Infections [ Time Frame: 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.


Enrollment: 808
Study Start Date: January 2012
Study Completion Date: March 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute leukemia patients
Patients with de novo or relapsed acute myeloid and lymphoid leukemia
Allo- or auto- transplant recipients

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 95 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This observational study will be implemented in the hematology departments or hematology centers with or without HSCT located throughout Russia.
Criteria

Inclusion Criteria:

  • Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
  • All newly allogeneic or autologous transplant recipients during the study period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519648


Locations
Russian Federation
National Hematological Society
Moscow, Russian Federation, 119021
Sponsors and Collaborators
National Hematological Society, Russia
Investigators
Principal Investigator: Galina A Klyasova National Research Center for Hematology
  More Information

Responsible Party: National Hematological Society, Russia
ClinicalTrials.gov Identifier: NCT01519648     History of Changes
Other Study ID Numbers: RIFI
First Submitted: January 23, 2012
First Posted: January 27, 2012
Results First Submitted: June 18, 2014
Results First Posted: July 18, 2014
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by National Hematological Society, Russia:
Invasive fungal infection
Acute leukemia (AL)
Hematopoietic stem cell transplantation
Antifungal stewardship
Neutropenia
Hematological malignancies

Additional relevant MeSH terms:
Leukemia
Infection
Communicable Diseases
Mycoses
Invasive Fungal Infections
Neoplasms by Histologic Type
Neoplasms