Fusariosis in Solid-Organ Transplant Recipients | NCT00518778

Studies
Fusariosis in Solid-Organ Transplant Recipients

NCT00518778

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Dec 3, 2009Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Solid Organ Transplant
Fusariosis

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

ID	Type	Description	Link
investigator funding	Other Identifier	UPMC

Status Module

Record Verification Date

Dec 2009

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 2007

Primary Completion Date

Not provided

Completion Date

Dec 2009Actual

First Submitted Date

Aug 17, 2007

First Submission Date that Met QC Criteria

Aug 20, 2007

First Posted Date

Aug 21, 2007Estimated

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

Dec 2, 2009

Last Update Posted Date

Dec 3, 2009Estimated

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

Detailed Description

This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.This will help determine prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.

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

50Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Solid-organ transplants (liver, kidney, lung, heart, pancreas, small bowel transplant) diagnosed with fusariosis or infections due to Fusarium, species in our institution

Exclusion Criteria:

Those subjects that do not meet inclusion criteria

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

Solid organ transplant patients diagnosed with fusariosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adarsh Bhimraj, 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
D060585	Fusariosis

Ancestor Terms

ID	Term
D060605	Hyalohyphomycosis
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

Browse Leaves

Not provided

Browse Branches

Not provided