Staphylococcus AureusNCT04574752
MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
An observational study of Staphylococcus Aureus and Next Generation Sequencing, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
The aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus, Next Generation Sequencing, Total Joint Arthroplasty
- What is being tested?
- next generation sequencing
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2020to 30 Aug 2021
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible
Who may be able to join
- All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible.
Who cannot join
- Patients included in other prospective studies
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
The aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients
- Being tested
- next generation sequencing
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
next generation sequencingDiagnostic test
diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques on S. aureus detection in orthopaedic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic techniques to identify S. aureus in total joint replacement patients
to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start30 Aug 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574752
- Sponsor's protocol ID
- JPARV20D.165
- Status last verified
- Sep 2020
- First submitted
- 29 Sep 2020
- Last updated
- 5 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
- ClinicalTrials.gov ID
- NCT04574752
- Acronym / sponsor ID
- JPARV20D.165
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 30 Aug 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 5 Oct 2020 (actual)
- 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 aims of this study were to evaluate the diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques and to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible
Key inclusion criteria (1 listed)
- All patients undergoing primary total knee or total hip arthroplasty at our institution will be eligible.
Key exclusion criteria (1 listed)
- Patients included in other prospective studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| next generation sequencingdiagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques on S. aureus detection in orthopaedic patients | Diagnostic test | – |
Primary outcome
Diagnostic techniques to identify S. aureus in total joint replacement patients
Time frame: 1 day
to model the potential effect of different diagnostic techniques on S. aureus detection in orthopaedic patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Individual participant dataSharing planned: No
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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 Next Generation Sequencing, run by Rothman Institute Orthopaedics 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 1 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: status not confirmed, as of the sponsor's last update on 5 Oct 2020. 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?
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.
What does the primary outcome measure?
Diagnostic techniques to identify S. aureus in total joint replacement patients (time frame: 1 day). 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 5 Oct 2020.