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Rapid Test to Detect Staphylococcus Aureus in Blood and Wound Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01198262
First Posted: September 10, 2010
Last Update Posted: September 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Baylor College of Medicine
Cepheid
Information provided by:
VA Medical Center, Houston
  Purpose
The purpose of this study is to determine whether the Cepheid GeneXpert system accurately detects Methicillin-Resistant and -Susceptible Staphylococcus aureus in blood cultures and wound swabs.

Condition
Staphylococcus Aureus Staphylococcal Skin Infections Bacteremia

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: GeneXpert in Studying Staphylococcus Aureus Infections at the Michael E. DeBakey Medical Center, Houston, Texas

Resource links provided by NLM:


Further study details as provided by VA Medical Center, Houston:

Primary Outcome Measures:
  • concordance between PCR results and those of standard bacteriologic culture [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Impact of early identification of S. aureus on the antibiotics prescribed by physicians and subsequent clinical outcome. [ Time Frame: 1 year ]

Enrollment: 260
Study Start Date: April 2008
Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Staphylococcus aureus (SA) remains a major pathogen for human beings, causing infections of skin, soft tissue, bone, and other organs. Bacteremia due to this organism is common, and often occurs in association with medical interventions such as intravenous lines and implantable devices. With the increase in methicillin-resistant S. aureus (MRSA), there has been increasing dependence upon vancomycin, a drug that is inferior to the beta-lactams in its activity against methicillin-susceptible S. aureus (MSSA). If the microbiology laboratory had the ability to identify S. aureus (SA) and its drug susceptibility within hours rather than days, focused therapy would be possible earlier in the course of illness. Clinicians would be able to discontinue antibiotics when SA is not present, to discontinue other broad-spectrum antibiotics when SA is present, or to replace empiric vancomycin with nafcillin when MSSA is identified.

The GeneXpert system (Cepheid) uses real-time PCR to detect genes that encode Staphylococcus aureus protein A (SPA), the staphylococcal cassette chromosome (SCC) and methicillin resistance (mecA). All blood cultures with Gram stain revealing Gram positive cocci in clusters will be tested by PCR the day they became positive. Wound swabs submitted for routine bacteriologic culture will be tested within 48 hr of collection. Results will be compared with those of standard bacteriologic culture. In addition, discrepancies between the GeneXpert and wound culture results will be reviewed in the medical record to ascertain whether antibiotic use at the time of specimen collection is associated with false positive results in which the wound culture yields no S. aureus but PCR detects staphylococcal DNA components.

In the second phase of the study, PCR results for wound swabs and blood cultures will be reported to physicians immediately upon completion of the reaction. The clinical impact of early identification of S. aureus will be determined by comparing antibiotic treatment and clinical outcome of patients for whom early identification was available with those of patients for whom conventional bacteriological culture was the sole diagnostic test.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population includes adult and geriatric patients at the Michael E. DeBakey VA Medical Center for have suspected blood and wound infections.
Criteria

Inclusion Criteria:

  • Positive blood culture with Gram stain revealing Gram positive cocci in clusters
  • All wound swabs submitted to the microbiology lab for standard bacteriologic culture may be included.

Exclusion Criteria:

  • Blood cultures that became positive more than 24 hours previously
  • Wound swabs for which over 48 hours have passed from the time of collection
  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): NCT01198262


Locations
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Medical Center, Houston
Baylor College of Medicine
Cepheid
Investigators
Principal Investigator: Daniel M Musher, MD MEDVAMC
Study Chair: Mark Parta, MD MEDVAMC
  More Information

Responsible Party: Daniel M Musher, Michael E. DeBakey VA Medical Center
ClinicalTrials.gov Identifier: NCT01198262     History of Changes
Other Study ID Numbers: H-23059
First Submitted: September 9, 2010
First Posted: September 10, 2010
Last Update Posted: September 10, 2010
Last Verified: October 2008

Keywords provided by VA Medical Center, Houston:
polymerase chain reaction

Additional relevant MeSH terms:
Infection
Communicable Diseases
Bacteremia
Skin Diseases, Infectious
Staphylococcal Skin Infections
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Skin Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Skin Diseases, Bacterial