Fungemia in Hematologic Malignancies

October 19, 2016 updated by: LIVIO PAGANO, Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

SEIFEM 2015: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

300

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

  • Italy
      • Rome, Italy, 00168
        • Catholic University Of Sacred Heart

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

No older than 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive adult and pediatric patients affected by hematologic malignancies and eligible to chemotherapy that develop fungemia

Description

Inclusion Criteria:

  • Patients diagnosed with hematologic malignancies and eligible to chemotherapy

Exclusion Criteria:

  • Patients not eligible to chemotherapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of fungemia outbreak during antifungal prophylaxis
Time Frame: Since 30 days average before fungemia onset
Since 30 days average before fungemia onset

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality from fungemia
Time Frame: After 30 days from fungemia onset
After 30 days from fungemia onset

Collaborators and Investigators

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

Sponsor

Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne

Investigators

  • Principal Investigator: Livio Pagano, Professor, Catholic University of Sacred Heart, Rome Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 13, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 19, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEIFEM 2015

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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