Lower Resp Tract InfectionLRTINCT03361670

Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel

An observational study of Lower Resp Tract Infection, run by BioFire Diagnostics, LLC at 8 sites in United States.

Completed

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

Trial summary

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate performance data to support regulatory… Read more about this study

Who is it for?: Any age
Conditions the study is for: Lower Resp Tract Infection
What is being tested?: Observational Study
How many people: 1,689 participants
Where: 8 sitesUnited States
Study dates: Oct 2016to Jul 2017
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Only residual BAL or sputum specimens from patients with clinician-ordered lower respiratory pathogen testing will be enrolled.

Who may be able to join

Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
Specimen has not been centrifuged
Specimen has not been pre-treated
Specimen has at least 1.5 mL of residual volume
Specimen was collected from a subject not already enrolled in the study
Specimen is fresh (stored at ~4°C, not frozen) and was enrolled with 24 hours of collection

Who cannot join

Specimen was centrifuged, pre-treated, or is less than 1.5mL
Specimen was collected from a subject known to have cystic fibrosis
Specimen was collected from a subject known to have tuberculosis
Specimen was collected from a subject that was previously enrolled in the study
Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University College of Medicine
Columbus, Ohio, 43210
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of California, Los Angeles
Los Angeles, California, 90095
Loyola University Medical Center
Maywood, Illinois, 60153
Wisconsin Medical Center
Milwaukee, Wisconsin, 53226
University of Nebraska Medical Center
Omaha, Nebraska, 68198

Other trials in United States

About this study

Official title: Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel

Read the detailed description

BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray. The FilmArray Lower Respiratory Tract Infection (LRTI) Panel is a test designed for use with the FilmArray that identifies common bacterial, viral, and fungal microorganisms as well as antimicrobial resistance gene targets associated with lower respiratory tract infections. The FilmArray LRTI Panel also provides quantitation for some bacterial analytes.

Clinical performance evaluations will be initiated at a minimum of three sites to determine the clinical performance of the FilmArray LRTI Panel for each of the analytes on the panel when testing bronchoalveolar lavage (BAL, including mini-BAL) and sputum (including endotracheal aspirates) specimens from subjects with suspected lower respiratory tract (LRT) infections. The intention is for these performance data to support regulatory classifications of the FilmArray LRTI Panel as an in vitro diagnostic device in the US, European Union (EU), Canada, and other regions. The study sites selected will have expertise in the diagnosis of LRTIs, and will be able to conduct the evaluation in accordance with this protocol and Good Clinical Practices (GCP). Prior to performing the prospective clinical evaluation, each participating site will have the necessary Institutional Review Board (IRB) or Ethics Committee (EC) reviews.

Specimens for inclusion in this study will be residual, de-identified BAL or sputum specimens leftover from clinician-ordered lower respiratory pathogen testing.

Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory and at BioFire.

This study is funded by BioFire Diagnostics, LLC.

Conditions: Lower Resp Tract Infection
Being tested: Observational Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Observational StudyOther

Study groups in NCT03361670
Study group	Role	What they receive
Specimens that meet inclusion criteria		Not described Receives: Other: Observational Study

What is being measured

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

sensitivity and specificity of device
Measured: 10 months

Timeline

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

Oct 2016Jul 2017

First posted5 Dec 2017
Study startOct 2016
Primary completionJul 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lower Resp Tract InfectionStudies 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: Case only
Time perspective: Prospective
Enrolment: 1,689 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03361670
Sponsor's protocol ID: DX-SDY-024947
Acronym: LRTI
Status last verified: Nov 2017
First submitted: 29 Nov 2017
Last updated: 5 Dec 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia

All Lower Resp Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel
ClinicalTrials.gov ID: NCT03361670
Acronym / sponsor ID: LRTI / DX-SDY-024947
Conditions: Lower Resp Tract Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 1,689 participants (actual)
Lead sponsor: BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
Study start: Oct 2016 (actual)
Primary completion: Jul 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 5 Dec 2017 (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.

Detailed description

Specimens for inclusion in this study will be residual, de-identified BAL or sputum specimens leftover from clinician-ordered lower respiratory pathogen testing.

Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory and at BioFire.

This study is funded by BioFire Diagnostics, LLC.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Specimens that meet inclusion criteria	–	Other: Observational Study

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Only residual BAL or sputum specimens from patients with clinician-ordered lower respiratory pathogen testing will be enrolled.

Key inclusion criteria (6 listed)

Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
Specimen has not been centrifuged
Specimen has not been pre-treated
Specimen has at least 1.5 mL of residual volume
Specimen was collected from a subject not already enrolled in the study

Key exclusion criteria (5 listed)

Specimen was centrifuged, pre-treated, or is less than 1.5mL
Specimen was collected from a subject known to have cystic fibrosis
Specimen was collected from a subject known to have tuberculosis
Specimen was collected from a subject that was previously enrolled in the study
Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.

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
Observational Study	Other	Specimens that meet inclusion criteria

Primary outcome

sensitivity and specificity of device
Time frame: 10 months

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 5 Dec 2017.
Individual participant dataSharing planned: No

Related trials for Lower Resp Tract Infection

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
Not yet recruitingPhase 3
A Study to Evaluate Efficacy, Immunogenicity and Safety of a Recombinant Respiratory Syncytial Virus Vaccine in Older Adults Aged 60 Years and Older
Respiratory Syncytial Virus (RSV), Respiratory Syncytial Virus (RSV) Infection
Not yet recruiting
Multimodal Stewardship Programme to Improve Antibiotic Prescribing for Children With Lower Respiratory Tract Infections
Bronchitis, Acute, Community-acquired Pneumonia

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.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Resp Tract Infection, run by BioFire Diagnostics, LLC at 8 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 6 inclusion and 5 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 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 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?

sensitivity and specificity of device (time frame: 10 months). 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 NCT03361670.

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 Dec 2017.