Lower Respiratory Tract InfectionsNCT05937126
Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia
An observational study of Lower Respiratory Tract Infections, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Respiratory Tract Infections
- What is being tested?
- FilmArray Pneumonia Panel and Culture and antimicrobial susceptibility testing
- How many people
- 1,203 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 19 Sep 2022
- 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: Lower respirator tract samples obtained from inpatient settings only (medical/surgical floors and intensive care units) at Mayo Clinic in Rochester, MN.
Who may be able to join
- Subjects who have the following samples collected and submitted for culture as part of routine clinical practice: Expectorated sputum, induced sputum, tracheal secretions, bronchoalveolar lavage.
Who cannot join
- Subjects who do not have MN Research Authorization on file
- Rejected sputum culture (i.e., due to low quality)
- Positive respiratory cultures within prior 7 days
- Deceased at time of sample randomization
- Any subject affected by Global Data protection Regulation (GDPR)
- Previous enrollment in the study.
- Outpatient status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia (RASP) - A Quality Improvement Theragnostic Stewardship Project
The purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.
- Conditions
- Lower Respiratory Tract Infections
- Being tested
- FilmArray Pneumonia Panel, Culture and antimicrobial susceptibility testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray Pneumonia PanelDiagnostic test
FDA-approved/cleared molecular, multiplex device that rapidly identifies viruses, bacteria, and antimicrobial resistance genes in sputum-like and bronchoalveolar lavage (BAL)-like specimens obtained from individuals with signs of a lower respiratory tract infection.
Culture and antimicrobial susceptibility testingDiagnostic test
Standard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Standard culture and antimicrobial susceptibility testing (AST) | Lower respiratory tract sputum samples (expectorated sputum, induced sputum, tracheal secretions, or bronchoalveolar lavage) collected in the inpatient setting per standard of care from adults with lower respiratory tract infections will receive standard culture and antimicrobial susceptibility testing (AST). Receives: Diagnostic Test: Culture and antimicrobial susceptibility testing | |
| Standard culture and AST PLUS rapid identification and AST | Lower respiratory tract sputum samples (expectorated sputum, induced sputum, tracheal secretions, or bronchoalveolar lavage) collected in the inpatient setting per standard of care from adults with lower respiratory tract infections will receive standard culture and AST PLUS rapid identification and AST using the FDA-approved/cleared FilmArray Pneumonia Panel Receives: Diagnostic Test: FilmArray Pneumonia Panel; Diagnostic Test: Culture and antimicrobial susceptibility testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until first modification of antibiotic therapy
Mean time until first modification of antibiotic therapy (in hours)
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start15 Sep 2020
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lower Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- 1,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Patel, Mayo Clinic
- Investigators
- Robin Patel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937126
- Sponsor's protocol ID
- 19-012521
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virk A, Strasburg AP, Kies KD, Donadio AD, Mandrekar J, Harmsen WS, Stevens RW, Estes LL, Tande AJ, Challener DW, Osmon DR, Fida M, Vergidis P, Suh GA, Wilson JW, Rajapakse NS, Borah BJ, Dholakia R, Reed KA, Hines LM, Schuetz AN, Patel R. Rapid multiplex PCR panel for pneumonia in hospitalised patients with suspected pneumonia in the USA: a single-centre, open-label, pragmatic, randomised controlled trial. Lancet Microbe. 2024 Dec;5(12):100928. doi: 10.1016/S2666-5247(24)00170-8. Epub 2024 Oct 17.
PubMed 39426396
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnostic Supporting Antimicrobial Stewardship in Patients With Pneumonia (RASP) - A Quality Improvement Theragnostic Stewardship Project
- ClinicalTrials.gov ID
- NCT05937126
- Acronym / sponsor ID
- 19-012521
- Conditions
- Lower Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,203 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 10 Jul 2023 (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 purpose of this study is to determine whether or not the FilmArray Penumonia Panel adds value to patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard culture and antimicrobial susceptibility testing (AST) | – | Diagnostic Test: Culture and antimicrobial susceptibility testingLower respiratory tract sputum samples (expectorated sputum, induced sputum, tracheal secretions, or bronchoalveolar lavage) collected in the inpatient setting per standard of care from adults with lower respiratory tract infections will receive standard culture and antimicrobial susceptibility testing (AST). |
| Standard culture and AST PLUS rapid identification and AST | – | Diagnostic Test: FilmArray Pneumonia Panel, Diagnostic Test: Culture and antimicrobial susceptibility testingLower respiratory tract sputum samples (expectorated sputum, induced sputum, tracheal secretions, or bronchoalveolar lavage) collected in the inpatient setting per standard of care from adults with lower respiratory tract infections will receive standard culture and AST PLUS rapid identification and AST using the FDA-approved/cleared FilmArray Pneumonia Panel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lower respirator tract samples obtained from inpatient settings only (medical/surgical floors and intensive care units) at Mayo Clinic in Rochester, MN.
Key inclusion criteria (1 listed)
- Subjects who have the following samples collected and submitted for culture as part of routine clinical practice: Expectorated sputum, induced sputum, tracheal secretions, bronchoalveolar lavage.
Key exclusion criteria (7 listed)
- Subjects who do not have MN Research Authorization on file
- Rejected sputum culture (i.e., due to low quality)
- Positive respiratory cultures within prior 7 days
- Deceased at time of sample randomization
- Any subject affected by Global Data protection Regulation (GDPR)
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 |
|---|---|---|
| FilmArray Pneumonia PanelFDA-approved/cleared molecular, multiplex device that rapidly identifies viruses, bacteria, and antimicrobial resistance genes in sputum-like and bronchoalveolar lavage (BAL)-like specimens obtained from individuals with signs of a lower respiratory tract infection. | Diagnostic test | Standard culture and AST PLUS rapid identification and AST |
| Culture and antimicrobial susceptibility testingStandard of care Gram stain, culture and other clinically ordered tests will be performed per standard practice. | Diagnostic test | Standard culture and AST PLUS rapid identification and AST, Standard culture and antimicrobial susceptibility testing (AST) |
Primary outcome
Time until first modification of antibiotic therapy
Time frame: 96 hours
Mean time until first modification of antibiotic therapy (in hours)
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 10 Jul 2023.
- Derived from this study: PubMed 39426396Virk A, Strasburg AP, Kies KD, Donadio AD, Mandrekar J, Harmsen WS, Stevens RW, Estes LL, Tande AJ, Challener DW, Osmon DR, Fida M, Vergidis P, Suh GA, Wilson JW, Rajapakse NS, Borah BJ, Dholakia R, Reed KA, Hines LM, Schuetz AN, Patel R. Rapid multiplex PCR panel for pneumonia in hospitalised patients with suspected pneumonia in the USA: a single-centre, open-label, pragmatic, randomised controlled trial. Lancet Microbe. 2024 Dec;5(12):100928. doi: 10.1016/S2666-5247(24)00170-8. Epub 2024 Oct 17.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Robin Patel, MD principal investigator
Mayo Clinic
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 Lower Respiratory Tract Infections, run by Mayo Clinic 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 7 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 Jul 2023. 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?
Time until first modification of antibiotic therapy (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937126, which also lists 1 linked publication.
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 Jul 2023.