Procalcitonin Test Reference Range Determination

Healthy Clinical Trial

— PRO-H  

Official title:

Clinical Evaluation To Determine The Expected Values Distribution Of Procalcitonin For The RAMP® Procalcitonin Test In A Healthy Reference Population (PRO-H)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591121
• Other study ID #: CSP025
• Status: Completed
• Phase: N/A
• First received: October 23, 2015
• Last updated: November 13, 2015
• Start date: October 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Response Biomedical Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Canada	Mt. Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Response Biomedical Corp.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procalcitonin value for healthy reference subjects	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.	Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.	No