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OpenTrials
Completed

NCT Number: NCT03606382

Collection of Clinical Specimens From Volunteers for Assay Development

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

Completed

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inflammatix, Inc.

Burlingame, California, 94010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HostDx Fever Test

Diagnostic Test

HostDx Fever test to distinguish between viral and bacterial infections

HostDx Sepsis Test

Diagnostic Test

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

Primary outcomes

  1. Collection of Specimens from Volunteers for the Development and Validation of HostDx Tests

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Inflammatix

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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