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

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ClinicalTrials.gov Identifier: NCT00906633
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : January 26, 2010
Sponsor:
Collaborator:
Catholic University of the Sacred Heart
Information provided by:
University Hospital, Udine, Italy

Brief Summary:
This trial is an observational study about combination antifungal therapy in hematologic patients with proven and probable invasive fungal infections (IFI).

Condition or disease
Fungal Infection

Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Seifem Observational Study of Antifungal Combination Therapy In Hematologic Italian Centers
Study Start Date : January 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Outcome of combination antifungal therapy



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


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

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

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 Posted: May 21, 2009    Key Record Dates
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