Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
Catholic University of the Sacred Heart
Information provided by:
University Hospital, Udine, Italy
ClinicalTrials.gov Identifier:
NCT00906633
First received: May 19, 2009
Last updated: January 25, 2010
Last verified: May 2009
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: May 19, 2009
Last Updated: January 25, 2010
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on September 29, 2016