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

July 18, 2014 updated by: National Hematological Society, Russia
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

808

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 95 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute leukemia patients
Patients with de novo or relapsed acute myeloid and lymphoid leukemia
Allo- or auto- transplant recipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hematological Society, Russia

Investigators

  • Principal Investigator: Galina A Klyasova, National Research Center for Hematology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 26, 2012

First Posted (ESTIMATE)

January 27, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIFI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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