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A Retrospective Review of Infections Usually Observed in Transplant Recipients

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by EJ Kwak, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
EJ Kwak, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00298077
First received: February 27, 2006
Last updated: June 8, 2017
Last verified: June 2017
  Purpose
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
Infection

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: A Retrospective Review of Infections Usually Observed in Transplant Recipients

Further study details as provided by EJ Kwak, University of Pittsburgh:

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.

Estimated Enrollment: 500
Study Start Date: August 2006
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: November 2025 (Final data collection date for primary outcome measure)
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
  Eligibility

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
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: 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
Study First Received: February 27, 2006
Last Updated: June 8, 2017

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

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on August 16, 2017