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Staphylococcus AureusNCT01198262

Rapid Test to Detect Staphylococcus Aureus in Blood and Wound Infections

An observational study of Staphylococcus Aureus and Staphylococcal Skin Infections, run by Michael E. DeBakey VA Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
260 participants
Where
1 siteUnited States
Study dates
Apr 2008to Aug 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Michael E. DeBakey VA Medical Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
polymerase chain reaction
Medical subject headings
Staphylococcal Infections, Staphylococcal Skin Infections, Bacteremia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. concordance between PCR results and those of standard bacteriologic culture

    Measured: 1 year

Secondary outcomes (1)
  1. Impact of early identification of S. aureus on the antibiotics prescribed by physicians and subsequent clinical outcome.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2010 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2009
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Retrospective
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01198262
Sponsor's protocol ID
H-23059
Status last verified
Oct 2008
First submitted
9 Sep 2010
Last updated
10 Sep 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Staphylococcus Aureus and Staphylococcal Skin Infections, run by Michael E. DeBakey VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

concordance between PCR results and those of standard bacteriologic culture (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2010.

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