Fungemia in Hematologic Malignancies

The purpose of this study is to determine the risk factors for fungemia in a population of patients diagnosed with hematologic malignancies and eligible for chemotherapy.

Completed

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Key information

Conditions

Acute Leukemia Bacterial Infections and Mycoses Blood Protein Disorders Cardiovascular Diseases Chronic Leukemia Fungemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Infections Inflammation Invasive Fungal Infections Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Mycoses Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of Sacred Heart

Rome, 00168, Italy

About this study

The coordinating center provides all participating centers with an epidemiologic form, in order to collect data in a comparable way. The requested informations include type of malignancy and its treatment, environmental expositions, laboratory work up, antifungal prophylaxis, clinical signs of infection, microbiological findings, antifungal therapy and outcome of infection at 30 days.

The planned sample size is about 300 patients to be recruited in 35 participating center over 5 years, in a retrospective-prospective fashion. Data check will be performed at the coordinating center. Missing data will be managed to minimize incomplete reports.

Statistical analysis will be performed by an independent reviewer, in order to assess risk factors predictive of fungal infection and outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with hematologic malignancies and eligible to chemotherapy

Exclusion criteria

Patients not eligible to chemotherapy

Treatment and study plan

Primary outcomes

Rate of fungemia outbreak during antifungal prophylaxis

Time frame: Since 30 days average before fungemia onset

Secondary outcomes

Mortality from fungemia

Time frame: After 30 days from fungemia onset

Sponsors and collaborators

Lead sponsor

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Other

Registry information

Official study title

SEIFEM 2015: Fungemia in Hematologic Malignancies

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2016
First posted: May 22, 2015
Registry last updated: Oct 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed