Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel
Public ClinicalTrials.gov record NCT03361670. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 classification of the FilmArray LRTI as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.
Study identification
- NCT ID
- NCT03361670
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,689 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2016
- Primary completion
- Jun 30, 2017
- Completion
- Jun 30, 2017
- Last update posted
- Dec 4, 2017
2016 – 2017
United States locations
- U.S. sites
- 8
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| The Ohio State University College of Medicine | Columbus | Ohio | 43210 | — |
| Wisconsin Medical Center | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03361670, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2017 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03361670 live on ClinicalTrials.gov.