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:
Information provided by (Responsible Party):
National Hematological Society, Russia
ClinicalTrials.gov Identifier:
NCT01519648
First received: January 23, 2012
Last updated: June 18, 2014
Last verified: June 2014
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   1 Year to 95 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Hematological Society, Russia
ClinicalTrials.gov Identifier: NCT01519648     History of Changes
Other Study ID Numbers: RIFI
Study First Received: January 23, 2012
Results First Received: June 18, 2014
Last Updated: June 18, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

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
Mycoses
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 20, 2014