Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI)

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.

See also
Status	Clinical Trial	Phase
Completed	`NCT01728363` - Pharmacokinetics (PK) of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)	Phase 1
Completed	`NCT04731584` - Systemic Inflammation During Recanalization of Cerebral Arterial Occlusion
Recruiting	`NCT05841875` - Efficacy and Safety of a Protocol Using C-reactive Protein to Guide Antibiotic Therapy	N/A

NCT number	NCT03064100
Study type	Observational
Source	BioFire Diagnostics, LLC
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	March 21, 2017
Completion date	February 2018

Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms