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Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients

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ClinicalTrials.gov Identifier: NCT00304330
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The information collected will provide insight in to the epidemiology of antibiotic resistance in a transplant compared to a non-transplant population. Data is needed regarding the date of admission, date of bloodstream infection and location of ward/ICU so trends in the emergence of resistance and antibiotic usage can be detected.

Condition or disease
Gram Negative Infection

Detailed Description:
We need to collect details on the demographics (age, sex etc), underlying conditions, transplant types and immunosuppression, in-hospital antibiotic management and clinical outcomes so that the effect of antibiotic resistance on patient outcome can be measured. We also need to collect microbiology and pathology data to determine the antibiotic susceptibility profile of the involved organisms. The following variables will be followed: time and location of positive cultures, underlying diseases and severity of illness, prophylactic antimicrobials, physical exam findings, laboratory and radiographical data, empiric antimicrobial usage, microbiological data and resistance patterns, choice of antibiotic once organism identified, suspected source of infection, microbiological and clinical outcomes, laboratory results, demographic information, medications, gender, weight, ethnicity, and past medical history

Study Design

Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Emergence of Gram-negative Resistance in Blood Culture Isolates of Solid-organ Transplant Recipients; a Comparative Study With a Non-transplant Population
Study Start Date : September 2006
Primary Completion Date : June 2017
Study Completion Date : June 2017
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
gram negative organisms
Criteria

Inclusion Criteria:

  • All patients with a positive blood culture isolate growing a gram-negative organism will be included from 1996 - 2005
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): NCT00304330


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: David L Paterson, MD University of Pittsburgh
More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00304330     History of Changes
Obsolete Identifiers: NCT00332423
Other Study ID Numbers: IRB# 0602123
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by University of Pittsburgh:
gram negative infection