Clinical trials: Multiplex PCR
Infectious Gastroenteritis
Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious…
- Trial name
- IMPACT (NCT02248285)
- Testing
- FilmArray™ Gastrointestinal (GI) Panel
- Where
- 5 sites in United States
- Volunteers
- 1,545 people
- Sponsor
- BioFire Diagnostics, LLC
Upper Respiratory Infections
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories…
- Trial name
- NCT02232711
- Where
- 4 sites in United States
- Volunteers
- 1,082 people
- Sponsor
- BioFire Diagnostics, LLC
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Respiratory Tract Infections (RTI), Influenza-like Illness
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments.
- Conditions
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- Trial name
- CARE4KIDS (NCT07453914)
- Testing
- SPOTFIRE R
- Where
- 3 sites in France, Greece and 1 more
- Volunteers
- 720 people
- Sponsor
- BioMérieux
Acute Respiratory Infections (ARIs)
Impact of a Multiplex Respiratory PCR Test on Outcomes for Patients Presenting With Respiratory Illness in the Urgent Care Setting: A Hybrid-Effectiveness Quasi-Experimental Trial
This research study will use a hybrid effectiveness-implementation type 1 design to assess effectiveness of the Spotfire R/ST assay in the urgent care setting.
- Trial name
- NCT07513519
- Testing
- SPOTFIRE R/ST Diagnostic Test
- Where
- 2 sites in United States
- Volunteers
- 800 people
- Sponsor
- BioMérieux