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

NCT ID: NCT01519648

Last Updated: 2014-07-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

808 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Invasive Fungal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute leukemia patients

Patients with de novo or relapsed acute myeloid and lymphoid leukemia

No interventions assigned to this group

Allo- or auto- transplant recipients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

1 Year

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hematological Society, Russia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galina A Klyasova

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Hematology

Locations

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National Hematological Society

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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RIFI

Identifier Type: -

Identifier Source: org_study_id

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