Infectious Outcomes Following Pancreas Transplantation | NCT00332111

Studies
Infectious Outcomes Following Pancreas Transplantation

NCT00332111

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Pancreatic Transplantation

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

Apr 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

May 30, 2006

First Submission Date that Met QC Criteria

May 30, 2006

First Posted Date

Jun 1, 2006Estimated

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

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 proposed protocol aims to characterize the infectious episodes in pancreas transplant recipients under the current medical care. Knowing these patients infectious risks, the types of infections that commonly affect them and the morbidity and mortality associated with it will provide valuable information in the evaluation of the safety and efficacy of the current practices. The information generated by this study will also serve as the basis for development of strategies targeting prophylaxis of infectious episodes.

Detailed Description

The objectives of the study are:

To determine what is the frequency of infectious complications following pancreas transplantation
Characterize the clinical and microbiological aspects of the infectious complications following pancreas transplantation
Identify predictors for infection following pancreas transplantation
Determine the frequency of graft loss and associated mortality of infectious complications following pancreas 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

Retention

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30 day outcomes after transplantation	outcomes of transplant patients post transplant	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent pancreas with or without kidney transplantation at the University of Pittsburgh Medical Center from January 1st 2002 to December 31st 2005
Patients must be above 18 years of age
Patients undergoing retransplantation may be included.

Exclusion Criteria:

History of pancreas transplantation at another institution

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 pancreatic and kidney transplants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

Description

No genetic testing will be performed on any of the samples being obtained. The biologic samples will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location. The investigators on this study will keep the samples indefinitely. If a subject withdraws and provides the request in writing, samples collected and not already processed will be destroyed. All samples will be kept in the investigator's laboratory located in Scaife Hall, Room 812, 3550 Terrace Street.