Rapid Test to Detect Staphylococcus Aureus in Blood and Wound Infections

Bacteremia Clinical Trial

Official title:

GeneXpert in Studying Staphylococcus Aureus Infections at the Michael E. DeBakey Medical Center, Houston, Texas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198262
• Other study ID #: H-23059
• Status: Completed
• Phase: N/A
• First received: September 9, 2010
• Last updated: September 9, 2010
• Start date: April 2008
• Est. completion date: August 2010

Study information

• Verified date: October 2008
• Source: VA Medical Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bacteremia
• Infection
• Skin Diseases, Infectious
• Staphylococcal Skin Infections
• Staphylococcus Aureus

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
VA Medical Center, Houston	Baylor College of Medicine, Cepheid

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	concordance between PCR results and those of standard bacteriologic culture		1 year	No
Secondary	Impact of early identification of S. aureus on the antibiotics prescribed by physicians and subsequent clinical outcome.		1 year	No