Clinical Evaluation of FilmArray LRTI Panel

Lower Respiratory Tract Infection Clinical Trial

Official title:

Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel BioFire Study #DX-SDY-024947

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02929680
• Other study ID #: 487-16-EP
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2016
• Last updated: September 21, 2017
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: September 2017
• Source: University of Nebraska
• Contact: Caitlin N Murphy, PhD
• Phone: 402-552-3305
• Email: caitlin.murphy[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel BioFire Study #DX-SDY-024947 is to collect data in support of the proposal to the FDA to support the classification of the LRTI panel as an in vitro diagnostic device for the diagnosis of lower respiratory tract infections. The study will enroll up to 1500 specimens across at least 3 study sites of sputum and bronchoalveolar lavage (BAL) specimens that are left over as excess from routine clinical care. Additionally, the study will collect residual whole blood or blood fractionation to evaluate the utility of procalcitonin (PCT) as an additional test to diagnose lower respiratory infection when it is available. Enrolled sputum and BAL specimens will be run on the FilmArray LRTI panel. If residual whole blood or blood fractionation is available it will be sent to BioFire Diagnostics, LLC where they will perform PCT testing. All specimens will be excess from routine standard of care testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Specimen is residual lower respiratory specimen (sputum, endotracheal aspirate, BAL, or mini-BAL) that was submitted under clinician order for standard of care

2. Specimen has not been centrifuged

3. Specimen has not been pretreated

4. Specimen has at least 1.5 ml of residual volume

5. Specimen was collected from a subject not already enrolled in the study

6. Specimen is fresh (stored at 4C, not frozen) and was enrolled with 24 hours of collection

Inclusion criteria for whole blood or blood fraction specimens (enrolled when available):

1. PCT testing was not performed as part of routine care for the subject on a blood fraction specimen that was collected within 12 hours of LRT specimens collection

2. Specimen is residual whole blood (heparinized) or blood fraction (e.g. plasma or serum) matched to a subject whose LRT specimen was enrolled in the study

3. Specimen was collected within 12 hours of the time that the LRT specimen was collected from the subject

4. Blood fraction (plasma or serum) is at least 0.25 mL of volume after fractionation

Exclusion Criteria:

1. Specimen was centrifuged, pre-treated, or is less than 1.5 mL

2. Specimen was collected from a subject known to have cystic fibrosis

3. Specimens was collected from a subject known to have tuberculosis

4. Specimen was collected from a subject that was previously enrolled in the study

5. Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours

Exclusion criteria for whole blood or blood fraction specimens:

1. PCT testing was performed as part of routine clinical care on a blood fraction

2. Specimen was not collected within 12 hours of corresponding LRT specimen

3. Blood fraction (plasma or serum) is less than 0.25 mL of volume after fractionation

Related Conditions & MeSH terms

• Infection
• Lower Respiratory Tract Infection
• Respiratory Tract Infections

Intervention

Device:
• FilmArray
Lower Respiratory specimens will be run on the BioFire FilmArray LRTI panel to evaluate its performance and collect data to support a proposal for the panel as an in vitro diagnostic device.

Locations

Country	Name	City	State
United States	Nebraska Medicine	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between LRTI results and culture and other comparator methods		6-12 months