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Seifem Surveillance of Antifungal Combination Therapy In Hematologic Italian Centers (SEIFEM COMBO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906633
First Posted: May 21, 2009
Last Update Posted: January 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Catholic University of the Sacred Heart
Information provided by:
University Hospital, Udine, Italy
  Purpose
This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).

Condition
Fungal Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers

Resource links provided by NLM:


Further study details as provided by University Hospital, Udine, Italy:

Primary Outcome Measures:
  • safety, efficacy and duration of therapy [ Time Frame: one year ]

Estimated Enrollment: 80
Study Start Date: January 2009
Study Completion Date: January 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Outcome of combination antifungal therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Haematologic patients with proven or probable invasive fungal infectious
Criteria

Inclusion Criteria:

  • Haematologic patients with proven or probable IFI
  • Therapy with a combination of antifungal drugs

Exclusion Criteria:

  • Haematologic patients with possible IFI
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906633


Locations
Italy
University Hospital, Udine
Udine, Italy, 33100
Sponsors and Collaborators
University Hospital, Udine, Italy
Catholic University of the Sacred Heart
Investigators
Principal Investigator: ANNA CANDONI, MD University Hospital, Udine, Italy
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CANDONI ANNA, UNIVERSITY HOSPITAL, Udine, Italy
ClinicalTrials.gov Identifier: NCT00906633     History of Changes
Other Study ID Numbers: SEIFEMcombo0509
First Submitted: May 19, 2009
First Posted: May 21, 2009
Last Update Posted: January 26, 2010
Last Verified: May 2009

Keywords provided by University Hospital, Udine, Italy:
antifungal therapies

Additional relevant MeSH terms:
Mycoses
Antifungal Agents
Miconazole
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors