Virulence Determinants in S Aureus Bacteremia

NCT00319826 | Completed

• 2 other identifiers: Pro0001407304-087
• Study Type: observational
• Target: 1,354
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacteremia

Keywords

Staphylococcus aureus, S. aureus, bacteremia, sepsis

Outcome Measures

Primary Outcomes (1)

• Cure vs. recurrence of Staph infection vs. death

  12 weeks

Study Arms (2)

1

Subjects with Staphylococcus Bacteremia

2

Healthy (Non-infected) Control Subjects in the Nasal Carriage Group

Other: No intervention

Interventions

No intervention OTHER

This is an observational study with no intervention

Also known as: Observational Study

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Bacterial strains are used from patients with particular syndromes (e.g. nasal carraige, endocarditis, osteomylitis) that were be identified using the Bloodstream Infections Registry. No new subjects was or will be enrolled within the current investigation.

You may qualify if:

• Adults (\>= 18 years) with culture-confirmed Staphylococcus aureus bacteremia (SAB). Patients with SAB transferred to Duke University Medical Center are eligible if speculation and antibiotic susceptibilities are confirmed by the Duke Clinical Microbiology Laboratory.
• Absolute neutrophil count of \> 1000 cells/cubic millimeter at the time that the initial positive blood culture is obtained.
• Patient or patient's representative provides signed informed consent allowing study participation.

You may not qualify if:

• Prior enrollment of patient in this investigation (to ensure statistical independence of observations).
• Staphylococcus aureus bacteremia (SAB) that is not confirmed by culture and speciation at the Duke Clinical Microbiology Laboratory.
• Outpatient status.
• Isolation of any pathogen other than S. aureus from bloodstream.
• Inability of patient or patient's representative to provide written informed consent.

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Bacteremia; Staphylococcal Infections; Sepsis

Interventions

Observation

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Vance G. Fowler, MD

  Duke UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2006
• First Posted: April 27, 2006
• Study Start: March 1, 2004
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

US (1)