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

A Potential Clinical Abdominal Infection Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912870
• Other study ID #: 2018-62
• Status: Completed
• Start date: December 10, 2018
• Est. completion date: May 11, 2023

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 11, 2023
• Est. primary completion date: June 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• A Potential Clinical Abdominal Infection Syndrome
• A Potential Infectious Respiratory Clinical Syndrome
• Communicable Diseases
• Infections
• Intraabdominal Infections
• Potential Clinical Urinary Infectious Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variables specifically measured for this study will be the flow cytometry assay of the two biomarkers (CD64, CD169)	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	96 hours