14 completed, 2 unknown, 1 enrolling by invitation, 1 terminated. 8 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 8 | Completed 7, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala Blood culture identification panel - Bacteremia, Sepsis | Not applicable | Completed | University of Colorado, Denver | 479 | 2022-04-07 | 2024-06-14 |
| Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients Septic Arthritis, Joint Infection | Completed | Olive View-UCLA Education & Research Institute | 750 | 2021-09-01 | 2026-06-25 | |
| Results of FilmArray® Gastro-intestinal Panel and Serum Procalcitonin in Acute Colitis and Infectious Diarrhea in the ER Filmarray PCR multiplex-PCT assay - Acute Diarrhea, Acute Colitis of Presumed Infectious Origin | Not applicable | Completed | Assistance Publique - Hôpitaux de Paris | 128 | 2020-03-09 | 2022-01-25 |
| Rapid Detection of Airway Pathogens for Lung Transplantation Lung Transplantation, Respiratory Tract Infections | Completed | University of California, San Francisco | 200 | 2019-03-19 | 2021-03-18 | |
| The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics Results available to provider - Respiratory Pathogens, Upper Respiratory Tract Illness | Not applicable | Completed | University of Colorado, Denver | 913 | 2019-01-03 | 2021-11-09 |
| Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea Biofire Film Array Gastrointestinal Panel - Infectious Diarrhea | Not applicable | Terminated | Andrew Meltzer | 74 | 2018-11-19 | 2022-12-20 |
| Collection of Anonymized Samples Healthy, Respiratory Disease | Enrolling by invitation | BioFire Diagnostics, LLC | 1500 | 2017-10-09 | 2017-10-24 | |
| Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing BioFire test platform - Respiratory Tract Infections, Gastrointestinal Infection | Unknown | BioFire Diagnostics, LLC | 4000 | 2017-10-05 | 2019-01-15 | |
| Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting FilmArray RP EZ - Respiratory Tract Infections | Not applicable | Completed | BioFire Diagnostics, LLC | 83 | 2017-04-04 | 2017-09-25 |
| Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel Observational Study - Systemic Infection | Unknown | BioFire Diagnostics, LLC | 1500 | 2017-03-21 | 2017-07-21 | |
| Pathogen Detection and Community Acquired Pneumonia FilmArray LRTI v.2.0 IUO Panel - Community Acquired Pneumonia | Not applicable | Completed | Providence Health & Services | 570 | 2017-01-01 | 2022-05-25 |
| Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department Rapid respiratory pathogen nucleic acid amplification test - Respiratory Tract Infections, Influenza, Human | Not applicable | Completed | University of California, Davis | 194 | 2016-12-08 | 2021-05-19 |
| Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel Observational Study - Lower Resp Tract Infection | Completed | BioFire Diagnostics, LLC | 1689 | 2016-10-01 | 2017-12-05 | |
| Prospective Clinical Evaluation of the FilmArray Respiratory Panel 2 Observational Study - Upper Resp Tract Infection | Completed | BioFire Diagnostics, LLC | 1612 | 2016-09-01 | 2017-01-12 | |
| Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel Observational study - Evaluation of Test Panel | Completed | BioFire Diagnostics, LLC | 1822 | 2015-12-01 | 2016-12-21 | |
| Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel Acute Fever | Completed | BioFire Diagnostics, LLC | 1514 | 2015-10-01 | 2016-12-21 | |
| Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study FilmArray™ Gastrointestinal (GI) Panel - Infectious Gastroenteritis | Not applicable | Completed | BioFire Diagnostics, LLC | 1545 | 2015-04-01 | 2017-12-26 |
| Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting Upper Respiratory Infections | Completed | BioFire Diagnostics, LLC | 1082 | 2014-11-01 | 2015-07-24 |
Respiratory Tract Infections (6) · Dysentery (2) · Emergencies (2) · Arthritis, Infectious (1) · Bacteremia (1) · Colitis (1) · Common Cold (1) · Communicable Diseases (1) · Community-Acquired Pneumonia (1) · Gastrointestinal Diseases (1) · Influenza, Human (1) · Pathologic Complete Response (1) · Respiration Disorders (1) · Sepsis (1) · Toxemia (1)
Observation (4)
United States (16) · France (1) · Guatemala (1)
Andrew Meltzer, MD, MS (1) · Christopher Polage, MD, MAS (1) · David Gilbert, MD (1) · John Greenland, MD, PhD (1) · Kevin Bourzac, PhD (1) · Larissa May, MD, MSPH (1) · Samuel Dominguez, MD, PhD (1)
PMID 32128326, PMID 34086034, PMID 38097379, PMID 40880253, PMID 42671259
R01AI104593 (1)