Invasive Fungal Infections Surveillance Initiative | NCT00177944

Studies
Invasive Fungal Infections Surveillance Initiative

NCT00177944

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

172Actual

Phase

Not provided

Conditions

Fungal Infection

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Name	Class
Astellas Pharma US, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

172Actual

Label	Type	Description	Intervention Names
patients with funal infections

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
outcome after invasive fungal infection	outcome after invasive fungal infection	60 days post infection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with funal infections

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernanda Silveira, MD	University of Pittsburgh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pittsburgh Medical Center		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D009181	Mycoses
D000072742	Invasive Fungal Infections

Ancestor Terms

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided