A Rapid Test for Acute Respiratory Illness

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

COMPLETED

Total Enrollment

783 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-17

Study Completion Date

2019-12-19

Brief Summary

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

The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.

Secondary objectives include:

1. Evaluate the effect of age on the performance of the HR-ARI test
2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
3. Evaluate the effect of geography on the performance of the HR-ARI test

Related Clinical Trials

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

FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test

NCT02018198

Acute Respiratory Tract Infections

COMPLETED

The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics

NCT03756753

Respiratory Pathogens Upper Respiratory Tract Illness Lower Respiratory Tract Illness +1 more

COMPLETED NA

Rapid Diagnostics for Upper Respiratory Infections in the Emergency Department

NCT02957136

Respiratory Tract Infections Influenza, Human Common Cold

COMPLETED NA

The Clinical Value of FA in AHLRI Patients

NCT03391076

Lower Respiratory Tract Infection

UNKNOWN NA

Improving Antibiotic Use in Acute Care Treatment

NCT00144040

Respiratory Infections

COMPLETED NA

Detailed Description

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

The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.

Secondary objectives include:

1. Evaluate the effect of age on the performance of the HR-ARI test
2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
3. Evaluate the effect of geography on the performance of the HR-ARI test

Subjects will be identified in the Emergency Department of participating hospitals. Samples including nasopharyngeal swab, throat swab, blood, and urine will be obtained.

A case report form for each subject will be completed to include information regarding clinical characteristics, signs and symptoms of infection, presence of complications, and patient outcome. Baseline characteristics including preexisting conditions. Survival data will also be collected for each subject.

Samples collected will be used to characterize the patient's illness as either infectious or not, and if infectious, either bacterial or viral. Samples will also be used to measure changes in gene expression, referred to as the Host Response-Acute Respiratory Illness (HR-ARI) test.

The result of this test will be made in comparison to a retrospective review of the subject's clinical information. Results will not be used for any interventions and will not be released to subjects or their providers.

Because the study procedure includes only sample and data collection, the risks will be minimal and no different than encountered during routine clinical care.

The study was re-assessed in 2020 and applicable updates were made to the record.

Conditions

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

Respiratory Tract Infection Acute Transcriptome Virus Disease Bacterial Infections

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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

Subjects with Acute Respiratory Illness

Patients with acute respiratory illness identified in the Emergency Department

Host Gene Expression

Intervention Type DIAGNOSTIC_TEST

comparison to retrospective clinical adjudication

Interventions

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

Host Gene Expression

comparison to retrospective clinical adjudication

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Adjudication

Eligibility Criteria

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

Inclusion Criteria

A. Age 24 months or older

B. Acute respiratory illness of less than 28 days in duration.

C. Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality:

* Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
* Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius.

D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required.

Exclusion Criteria

A. Known or suspected infection at any other anatomic site requiring antibacterial therapy.

B. Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No