Clinical trial NCT02591121: Procalcitonin Test Reference Range Determination
Official title: Clinical Evaluation To Determine The Expected Values Distribution Of Procalcitonin For The RAMP® Procalcitonin Test In A Healthy Reference Population (PRO-H)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Response Biomedical Corp.
Sponsor class: INDUSTRY
First posted: 2015-10-29
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy normal

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.

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

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)

Primary outcomes:
measure: Procalcitonin value for healthy reference subjects
timeFrame: Subjects will be followed for duration of one blood draw from one visit only; study enrollment will occur over 21 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mt. Sinai Hospital
state: Ontario
Study officials:
affiliation: Mount Sinai Services
name: Azar Azad
role: PRINCIPAL_INVESTIGATOR
References: