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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-21

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Rapid Blood Culture Identification Panel in Pediatric Patients in Guatemala

NCT05314816

Bacteremia Sepsis

COMPLETED NA

Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

NCT04147975

Bacteremia Candidemia

UNKNOWN

Pediatric Infectious Disease Precision Medicine Using Sequencing Evaluation of CSF

NCT03796546

Infection Meningitis

COMPLETED

A Retrospective, Blinded Validation of a Host-response Based Diagnostics

NCT01911143

Fever Respiratory Tract Infections Urinary Tract Infections +2 more

COMPLETED

A Combinatorial Biomarker for Infection Diagnosis in Children

NCT05971901

Respiratory Tract Infections Fever

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Specimens that meet inclusion criteria

Observational Study

Intervention Type OTHER

Exclusion from the study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational Study

Exclusion from the study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
* Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
* Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
* Specimen is at least 500 µL (1.5 mL collection desired)

Exclusion Criteria

* Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
* Physician determines that participation in the study is an unacceptable health risk
* Minimum volume requirement is not met

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No