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A Prospective Registry for Febrile Events in Patients With Malignant Hemopathies or Subjected to Haematopoietic Stem Cell Transplant

NCT01069887 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2010-02-24

No results posted yet for this study

Summary

Hema e-chart is an electronic case record that can be changed in real time and is based on the chronological organisation of the infective events and the therapies prescribed. It allows the collection of all personal, epidemiological, diagnostic and therapeutic data pertaining to the patient, processing it and analysing the results.

Aims and objectives of the project

The aims of this registry are:

* To assess how many suspected fungal-related febrile episodes identify an infective fungal agent
* To have a clear view of the diagnostic and therapeutic actions in the management of onco-haematological patients with suspected fungal-related febrile episodes
* To assess the impact of anti-fungal therapy on the timing of chemotherapy and transplant planning
* Perform drug-epidemiology relationship analyses, observe toxicity and interactions with antifungal therapies by means of the creation of a national database of fungal infections in patients affected by malignant haemopathies

Design

* A multicentre, prospective registry for monitoring invasive fungal infections in onco-haematological patients
* Registration criteria: patients with newly diagnosed malignant haematological diseases (acute and chronic myeloid and lymphoid leukaemia, multiple myeloma, non-Hodgkin's and Hodgkin's lymphoma, aplastic anaemia, myelodysplastic syndromes), or patients who, as a result of onco-haematological pathologies, have undergone allogenic or autologous haematopoietic cell transplants, and have ongoing febrile episodes . The recording of consecutive febrile events is required
* Data collection for each individual patient will be performed according to the method shown in the enclosed flow chart. In the case of a new episode for an existing patient, said new episode will be recorded in the same case record as a new event. All collected data will be coded into the database
* Information relating to about 500 suspected fungal-related febrile events requiring antifungal therapy is expected to be collected from approximately 60 centres over the course of 18 months
* Data collection for each event may be performed following the provision of written informed consent, which will be obtained from each patient participating in this health survey
* The data collected will be handled and stored in full compliance with the Italian laws governing privacy
* Hema e-chart is a non-interventional registry

Conditions

Sponsors & Collaborators

  • Pagano L, Aversa F, Locatelli F, Nosari A,Rossi G, Viale P

    collaborator UNKNOWN

  • Catholic University of the Sacred Heart

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Completion
2009-03-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01069887 on ClinicalTrials.gov