Procalcitonin Test Reference Range Determination

NCT ID: NCT02591121

Last Updated: 2015-11-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2015-10-31

Brief Summary

Prospective, single-centre study in healthy volunteers to establish a reference range for the RAMP Procalcitonin (PCT) test. The primary objective of this study is to establish the reference range for measurement of PCT levels using the RAMP Procalcitonin test.

Detailed Description

Healthy volunteers who meet eligibility criteria and have provided informed consent will be enrolled in this study. Each participant will be required to donate 1 blood sample via standard venipuncture into an EDTA (lavender top) tube for testing on one occasion. The maximum trial duration for each participant is one visit/occasion. Sample collection will take place within a single clinical session. The maximum trial duration for each participant is one clinic session.

Conditions

Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Apparently healthy (as determined by a subject questionnaire) males or females, of any race
• >18 years of age
• Willing to voluntarily agree to sign a consent form

• Investigator believes subject is unsuitable for inclusion in the trial (i.e. has major condition(s) or other reason(s) that could limit their ability to participate in the study; or impact the scientific integrity of the study)

Exclusion Criteria

• Meets the definition for one or more of Systematic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock and/or Multiple Organ Dysfunction Syndrome (MODS) as defined by The American College of Chest Physicians (ACCP) and the Society of Critical Care Medicine (SCCM) consensus conference in 1992.
• Current diagnosis, or history, of any underlying major medical condition such as heart disease, hypertension/hypotension, stroke, renal disease, chronic obstructive pulmonary disorder, diabetes, bleeding disorders, hypercalcitoninemia, HIV, etc.
• Bacterial, fungal or malaria infection within previous 12 months
• Have experienced or undergone trauma, surgery, cardiac shock and/or a burn within previous 3 months
• Current diagnosis of cancer and/or has undergone Immunotherapy which stimulates cytokines in the previous 12 months
• Hospitalization (for >24 hours) within previous 3 months
• Currently pregnant or nursing a child
• Unable, or unwilling, to provide required blood sample for testing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Response Biomedical Corp.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Azar Azad

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Services

Locations

Mt. Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CSP025

Identifier Type: -

Identifier Source: org_study_id