Collection of Clinical Specimens From Volunteers for Assay Development

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03606382

Enrollment

Registered

2018-07-30

Start date

2018-04-01

Completion date

2019-05-01

Last updated

2019-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Infection

Brief summary

This study will analyze gene expression data from various biological specimens collected from voluntary participants.

Detailed description

Primary objective is the collection of specimens from volunteers for the development and validation of HostDx tests. The study does only encompass specimen collection - Therefore, no traditional endpoint is defined but rather the successful collection of clinical specimens is defined as the endpoint.

Interventions

DIAGNOSTIC_TESTHostDx Fever Test

HostDx Fever test to distinguish between viral and bacterial infections

DIAGNOSTIC_TESTHostDx Sepsis Test

HostDx Fever test to determine the severity of a presented, suspected infection.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years of age or greater * Able to provide informed consent

Exclusion criteria

* Known pregnancy * Inability to understand instructions and comply with study related procedures

Design outcomes

Primary

Measure	Time frame	Description
Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests	1 Day	Blood collection, upper respiratory specimens including. nasal swabs, nasal washes, nasopharyngeal swabs, buccal swabs, buccal washes), sputum, saliva, urine and a skin/soft-tissue specimen (dermal).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026