Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319826
Status:
COMPLETED
Last Update Posted:
2016-04-28
First Post:
2006-04-27
Brief Title:
Virulence Determinants in S Aureus Bacteremia
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Virulence Determinants in Staphylococcus Aureus Bacteremia
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate why some people develop life-threatening infections caused by the bacteria Staphylococcus aureus while other people do not It is possible that the infectious ability of the bacteria can determine whether an infection develops and its severity The investigators will look at old blood and nasal specimens collected from 1000 adults who had S aureus infections and who were hospitalized at Duke University Medical Center Previously collected health information regarding these patients and the specific bacterial traits in the samples will be studied Eventually this information may be used to help treat and prevent S aureus infection
Detailed Description:
The purpose of this study is to more thoroughly investigate the impact of bacterial genetic characteristics on the outcome of patients with S aureus bacteremia SAB The investigators will address salient aspects of bacterial virulence using strong collaborative relationships with authorities in bacterial genetics and genomics The overall hypothesis of this investigation is that distinct bacterial virulence determinants influence the severity of S aureus infection The specific hypothesis is that virulence determinants associated with clinical outcome of S aureus infection segregate into clonal groups identified by Multilocus Sequence Typing MLST and can be localized in the genome by comparative genetic hybridization CGH The investigators have established the following aims to pursue this hypothesis Specific Aim 1 Define the allelic diversity of S aureus bloodstream isolates using MSLT Allelic profiles among the 1000 isolates will be compared using the program BURST Based Upon Related Sequence Type and relatedness of lineages in the overall collection will be defined Specific Aim 2 Define the genomic diversity of S aureus bloodstream isolates using CGH Using MLST results a subset of 200 isolates will be selected to undergo further study These 200 isolates will form a unique collection hereafter referred to as the SAGA S aureus genomic analysis collection The genomic diversity of the SAGA subset will be defined using CGH Specific Aim 3 Correlate MLST and CGH results MLST and clinical outcome and CGH and clinical outcome and make SAGA isolates available to the scientific community In this Specific Aim the discriminate ability of MLST and CGH will be compared among the SAGA subset isolates undergoing both assays The association between bacterial clonality and clinical outcome will be considered among 1000 S aureus isolates collected from adults at Duke University Medical Center who had S aureus infections undergoing MLST The association between clinical outcome and the presence or absence of virulence factors and pathogenicity islands in the S aureus genome will also be considered among the 200 SAGA subset isolates undergoing CGH The products of this study will include an increased understanding of genetic diversity in S aureus and the role of this genetic diversity on determining the severity of infections caused by S aureus The full value of the current proposal also includes the potential future benefit to the research community as a whole if associations between pathogen genotype and clinical outcome only possible to identify using such a large and clinically well-characterized collection of isolates can be defined To amplify these potential downstream dividends the final goal of Specific Aim 3 will be to make SAGA subset isolates corresponding MLST types and CGH profiles available to the scientific community through the repository maintained by the Network for Antimicrobial Resistance in S aureus NARSA The long-term objectives of this project are to 1 identify bacterial genes contributing to the severity of infection in isolates from a large cohort of patients with SAB and 2 ultimately use these genes to identify novel interventions for the control of S aureus pathogenesis by investigating genes that govern the virulence of this emerging pathogen Culture-confirmed SAB nasal carriage isolates andor bloodstream bacterial isolates previously collected from 1000 inpatient adults at Duke University Medical Center will be used in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-087 | None | None | None |