Procalcitonin Test Reference Range Determination

Completed

• Conditions: Healthy

• Registration Number: NCT02591121
• Lead Sponsor: Response Biomedical Corp.

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.

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-28
• Study First Posted: 2015-10-29
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

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
• Non-compliance to the protocol or inclusion criteria
• 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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procalcitonin value for healthy reference subjects	Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.	Procalcitonin value for each subject will be determined within 2 hours of phlebotomy. At study completion all data obtained will be compiled and a 95th percentile value determined.

Trial Locations

Locations (1)

Mt. Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada