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A Retrospective Review of Infections Usually Observed in Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00298077
Recruitment Status : Recruiting
First Posted : March 1, 2006
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study will identify patients with infections commonly observed in transplant recipients, describe the epidemiology of their infection, study the risk factors associated with various infections and examine strategies of early diagnosis and prevention of infection

Condition or disease
Infection

Detailed Description:
The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, recent immunomodulative therapies, physical exam findings, previous medical surgical conditions, microbiology and virology culture results, laboratory and radiographical data, antimicrobial usage of onset of infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, suspected source of infection, bacteriological outcomes, laboratory results, demographic information, pathology and histology results, summaries of admissions, discharges, operations, death, medications, clinical outcome gender, height, weight, ethnicity, date of transplant, type of transplant, primary diagnosis, and past medical history. Also required are medical summaries of admissions, discharges, operations, and deaths

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective Review of Infections Usually Observed in Transplant Recipients
Study Start Date : August 2006
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : December 2025
Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples Without DNA
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
transplant recipients with infections
Criteria

Inclusion Criteria:

  • Patients who receive medical care at UPMC
  • Patients who developed infections usually observed in transplant recipients

Exclusion:

  • Patients who do not receive medical care in UPMC Oakland campus
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298077


Contacts
Contact: Eun Kwak, MD 412-648-6489 kwakej@upmc.edu
Contact: Diana Lynn Pakstis, RN, BSN 412-648-6553 dlp5@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: EJ Kwak, MD    412-648-6489    kwakej@upmc.edu   
Contact: Diana Lynn Pakstis, BSN    412-648-6553    dlp5@pitt.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Eun Kwak, MD University of Pittsburgh
More Information

Responsible Party: EJ Kwak, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00298077     History of Changes
Other Study ID Numbers: IRB# 0602053
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by EJ Kwak, University of Pittsburgh:
Infection
transplant recipients

Additional relevant MeSH terms:
Infection
Communicable Diseases