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Value of Flow Cytometry in Infectious Point of Care: Feasibility Study

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ClinicalTrials.gov Identifier: NCT03912870
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

The purpose of this project is to validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures. The results of these assays will be compared with the diagnoses made at the end of treatment in order to determine their sensitivity and specificity.

This study is the preliminary study, necessary to determine the detection characteristics of these biomarkers.


Condition or disease Intervention/treatment
A Potential Infectious Respiratory Clinical Syndrome Potential Clinical Urinary Infectious Syndrome A Potential Clinical Abdominal Infection Syndrome Other: Value of Flow Cytometry in Infectious Point of Care

Detailed Description:

The detection and characterization of infectious events is a major challenge for emergency medicine. Thus the possibility of quickly attributing an infectious origin to a febrile and/or inflammatory syndrome makes it possible to treat and refer the patient quickly. In addition, the ability to distinguish bacterial etiology from viral etiology provides a valuable additional indication for the clinician. This of the upmost importance for fragile populations such as elderly patients and in epidemic conditions such as influenza. A new rapid diagnostic guidance solution is proposed by the Beckman Coulter Laboratory with the simultaneous assay of two biomarkers, one allowing the detection of a viral infectious process (CD169), the other of a bacterial infectious process (CD64). The combination of these two biomarkers, measured in 12 minutes by a new generation assay and flow cytometer, represents an opportunity for emergency services.

To date, there is no study on the validation of this diagnostic orientation method. We propose to carry out a prospective, observational, non-interventional feasibility study to compare the results of these measurements with the usual diagnostic criteria combining the clinical signs, infectious testing, and biological data.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Interest of Flow Cytometry in Infectious Point of Care: Feasibility Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : September 30, 2019

Intervention Details:
  • Other: Value of Flow Cytometry in Infectious Point of Care

    To validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures. The results of these assays will be compared with the diagnoses made at the end of treatment in order to determine their sensitivity and specificity.

    This study is the preliminary study, necessary to determine the detection characteristics of these biomarkers.



Primary Outcome Measures :
  1. Variables specifically measured for this study will be the flow cytometry assay of the two biomarkers (CD64, CD169) [ Time Frame: 96 hours ]
    to validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient over 18 years of age presenting to the Timone 2 Emergency Department with the association
Criteria

Inclusion Criteria:

  • Patient over 18 years of age presenting to the Timone 2 Emergency Department with the association:

    • A fever> 38 ° C or hypothermia <36.5 ° C.
    • A potential clinical infectious syndrome is respiratory (cough, sputum, dyspnea), or urinary (potential urinary tract infection), or abdominal (potentially infectious diarrhea, potentially infectious pain syndrome) or neurological (meningitis potential) or cutaneous (erysipelas).

Exclusion Criteria:

  • Patients with clinical criteria that may increase other non-specific biomarkers and therefore not allow for subsequent comparison:

    • Trauma
    • Known inflammatory and autoimmune disease
    • Infectious chronic viral, fungal or bacterial disease
    • Antibiotic or anti viral treatment prior to admission
    • Immunosuppressive treatment
    • neoplasia
    • Extended burn
    • Recent surgery (<1 month)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912870


Contacts
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Contact: PIERRE MICHELET 04 13 42 97 05 pierre.michelet@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille Cedex 5, France, 13354
Contact: Pierre Michelet    04 91 38 74 13 13    pierre.michelet@ap-hm.fr   
Contact: Alexandra Giuliani    0491382870    promotion.interne@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Pierre MICHELET Assistance Publique Hôpitaux de Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03912870     History of Changes
Other Study ID Numbers: 2018-62
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Intraabdominal Infections
Syndrome
Disease
Pathologic Processes