Methicillin ResistanceNCT00541632
BacLite Rapid MRSA Clinical Performance
An observational study of Methicillin Resistance, run by Solventum US LLC at 9 sites in United States.
Trial summary
The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Methicillin Resistance
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Oct 2007to Mar 2008
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18 years or older
- Subjects willing to document demographic characteristics
- Subjects willing to have their nose swabbed
- Subjects (or legal representative) willing to sign consent and authorization forms
Who cannot join
- Subjects who use Vicks Sinex Nasal spray or other nasal sprays
- Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects
- Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares
- Investigator believes that subject is unsuitable for inclusion.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Institute for Medical Research, Inc.
Atlanta, Georgia, 30030
University of Maryland
Baltimore, Maryland, 21201-1595
Cleveland Clinic
Cleveland, Ohio, 44195
Denver Health Medical Center
Denver, Colorado, 80204
Wayne State University
Detroit, Michigan, 48201
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
University of Iowa
Iowa City, Iowa, 52242
Washington University
St Louis, Missouri, 63110
Wake Forest University
Winston-Salem, North Carolina, 27157-1042
About this study
The purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.
- Conditions
- Methicillin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: performance variability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methicillin ResistanceStudies 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
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Werner E Bischoff, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541632
- Sponsor's protocol ID
- 010737
- Status last verified
- Nov 2024
- First submitted
- 6 Oct 2007
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BacLite Rapid MRSA Clinical Performance
- ClinicalTrials.gov ID
- NCT00541632
- Acronym / sponsor ID
- 010737
- Conditions
- Methicillin Resistance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: performance variability
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Oct 2007 (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 purpose of this study is to compare the performance of the 3M(TM) BacLite (TM) Rapid MRSA test system to traditional culture methods in detecting the presence of Methicillin Resistant Staphylococcus aureus (MRSA) directly from nasal samples.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 18 years or older
- Subjects willing to document demographic characteristics
- Subjects willing to have their nose swabbed
- Subjects (or legal representative) willing to sign consent and authorization forms
Key exclusion criteria (4 listed)
- Subjects who use Vicks Sinex Nasal spray or other nasal sprays
- Subjects with prescribed nasal medical devices where collecting samples may resent more than minimal risk to subjects
- Subjects having nasal prosthetics, jewelry or trauma to the nose or anything that may prevents sampling the anterior nares
- Investigator believes that subject is unsuitable for inclusion.
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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: performance variability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
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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.
Werner E Bischoff principal investigator
Wake Forest University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methicillin Resistance, run by Solventum US LLC at 9 sites 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 was stopped early (reason given: performance variability). Results are not available in the source record.
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.
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 2 Dec 2024.