Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

Invasive Fungal Infections Surveillance Initiative

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177944
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to optimize the management of patients treated for invasive fungal infections by establishing a real-time, continuous clinical data base that will capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive fungal infections; reflect routine clinical management of patients with invasive fungal infections in order to evaluate treatment and provide a rationale for future treatment paradigms; and allow physicians to assess adherence to institutional clinical practice guidelines, validate current standardized definitions for patients with invasive fungal infections and promote change where appropriate.


Condition
Fungal Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Invasive Fungal Infections Surveillance Initiative

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • outcome after invasive fungal infection [ Time Frame: 60 days post infection ] [ Designated as safety issue: No ]
    outcome after invasive fungal infection
Enrollment: 172
Study Start Date: August 2005
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with funal infections

Detailed Description:

Gender, height, weight, ethnicity, antifungal treatment, fungal colonization, laboratory results, past medical history, invasive fungal infection diagnosis, medications, outcomes

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with funal infections

Criteria

Inclusion Criteria:

  • All patients with a diagnosis of proven or probable invasive fungal infection . This includes patients with proven or probable invasive mold infections as well as patients with proven candidemia.

Exclusion Criteria:

  • All patients with a diagnosis of possible invasive fungal infection . This includes patients with possible mold infections as well as patients with possible candidemia.
  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: NCT00177944

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Fernanda Silveira, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00177944     History of Changes
Other Study ID Numbers: IRB # 0503062
Study First Received: September 13, 2005
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
invasive fungal infection

Additional relevant MeSH terms:
Mycoses

ClinicalTrials.gov processed this record on March 03, 2015