Staphylococcus AureusMRSAVOCNCT01379053
Volatile Organic Compounds in Staphylococcus Aureus Patients
An observational study of Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus, run by Landon Pediatric Foundation at 1 site in United States.
Trial summary
The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus… Read more about this study
- Who is it for?
- Ages 1 year to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus, Methicillin-resistant Staphylococcus Aureus, Nosocomial Disease
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Dec 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 1 year to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be selected upon suspicion of MRSA or MSSA infection or colonization. Increased concentration will be give to selection of persons from the following high risk groups: * It has been documented that the patient has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission. * The patient will be admitted to an intensive care unit or burn unit of the hospital. * The patient receives inpatient dialysis treatment. * The patient is being transferred from a skilled nursing facility
Who may be able to join
- Suspicion of staphylococcus aureus infection or colonization
- Able to give samples for zNose® analysis
Who cannot join
- Inability to provide sample for zNose® analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Ventura County Medical Center Hospital
Ventura, California, 93003
About this study
Official title: Detection of Methicillin Resistant Staphylococcus Aureus Colonization Using the zNose®, an Ultra-fast Gas Chromatograph
The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists of:
- A collection apparatus for collection of volatile compounds from suspected infection sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate sample of room air.
- Analysis of the volatile organic compounds from suspected infection sites and room air by short acoustic wave gas chromatography.
- Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of Staphylococcus aureus infection and colonization.
This study will test the hypothesis that we can identify the presence of MRSA by sampling the "head space" above culture media of anterior nare samples provided by patients with MRSA. Additionally, this study will test the hypothesis that we can identify the presence of MRSA by sampling air exhaled through the nostrils (nasal exhalant).
- Keywords
- Staphylococcus aureus, Methicillin-resistant staphylococcus aureus, Nosocomial disease, Electronic nose, Gas chromatography
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Staphylococcus Patients | Patients suspected of having Methicillin-resistant and/or methicillin-susceptible staphylococcus aureus. | |
| Control | Healthy volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Methicillin Resistant Staphyloccus aureus
Identification during clinic visit of MRSA
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus AureusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris Landon, Landon Pediatric Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379053
- Sponsor's protocol ID
- MRSA1
- Acronym
- MRSAVOC
- Status last verified
- Aug 2014
- First submitted
- 21 Jun 2011
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Methicillin Resistant Staphylococcus Aureus Colonization Using the zNose®, an Ultra-fast Gas Chromatograph
- ClinicalTrials.gov ID
- NCT01379053
- Acronym / sponsor ID
- MRSAVOC / MRSA1
- Keywords
- Staphylococcus aureus, Methicillin-resistant staphylococcus aureus, Nosocomial disease, Electronic nose, Gas chromatography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The zNose® MRSA test is a non-invasive breath test for markers of Staphylococcus aureus, which may predict the probability of bacterial organisms in the anterior nares, throat and respiratory tract, wounds, and anus and therefore be able to replace or supplement current active Methicillin Resistant Staphylococcus Aureus (MRSA) surveillance efforts. It consists of:
- A collection apparatus for collection of volatile compounds from suspected infection sites onto a sorbent trap or Tedlar bag, as well as for the collection of a separate sample of room air.
- Analysis of the volatile organic compounds from suspected infection sites and room air by short acoustic wave gas chromatography.
- Interpretation of the volatile organic compounds with a proprietary algorithm in order to predict the probability of Staphylococcus aureus infection and colonization.
This study will test the hypothesis that we can identify the presence of MRSA by sampling the "head space" above culture media of anterior nare samples provided by patients with MRSA. Additionally, this study will test the hypothesis that we can identify the presence of MRSA by sampling air exhaled through the nostrils (nasal exhalant).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staphylococcus Patients | – | –Patients suspected of having Methicillin-resistant and/or methicillin-susceptible staphylococcus aureus. |
| Control | – | –Healthy volunteer |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be selected upon suspicion of MRSA or MSSA infection or colonization. Increased concentration will be give to selection of persons from the following high risk groups: * It has been documented that the patient has been previously discharged from a general acute care hospital within 30 days prior to the current hospital admission. * The patient will be admitted to an intensive care unit or burn unit of the hospital. * The patient receives inpatient dialysis treatment. * The patient is being transferred from a skilled nursing facility
Key inclusion criteria (2 listed)
- Suspicion of staphylococcus aureus infection or colonization
- Able to give samples for zNose® analysis
Key exclusion criteria (1 listed)
- Inability to provide sample for zNose® analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of Methicillin Resistant Staphyloccus aureus
Time frame: one week
Identification during clinic visit of MRSA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Staphylococcus Aureus and Methicillin-resistant Staphylococcus Aureus, run by Landon Pediatric Foundation 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 1 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 13 Aug 2014. 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?
Identification of Methicillin Resistant Staphyloccus aureus (time frame: one week). 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 13 Aug 2014; AzTrials last refreshed its copy on 26 Oct 2026.