A Potential Infectious Respiratory Clinical SyndromeNCT03912870
Value of Flow Cytometry in Infectious Point of Care: Feasibility Study
An observational study of A Potential Infectious Respiratory Clinical Syndrome and Potential Clinical Urinary Infectious Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A Potential Infectious Respiratory Clinical Syndrome, Potential Clinical Urinary Infectious Syndrome, A Potential Clinical Abdominal Infection Syndrome
- What is being tested?
- Value of Flow Cytometry in Infectious Point of Care
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2018to 11 May 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient over 18 years of age presenting to the Timone 2 Emergency Department with the association
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- neoplasia
- Extended burn
- Recent surgery (<1 month)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Flow Cytometry in Infectious Point of Care: Feasibility Study
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.
Read the 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.
- Conditions
- A Potential Infectious Respiratory Clinical Syndrome, Potential Clinical Urinary Infectious Syndrome, A Potential Clinical Abdominal Infection Syndrome
- Being tested
- Value of Flow Cytometry in Infectious Point of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Value of Flow Cytometry in Infectious Point of CareOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start10 Dec 2018
- Primary completion5 Jun 2020
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A Potential Infectious Respiratory Clinical SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre MICHELET, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912870
- Sponsor's protocol ID
- 2018-62
- Status last verified
- May 2023
- First submitted
- 10 Apr 2019
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Flow Cytometry in Infectious Point of Care: Feasibility Study
- ClinicalTrials.gov ID
- NCT03912870
- Acronym / sponsor ID
- 2018-62
- Conditions
- A Potential Infectious Respiratory Clinical Syndrome, Potential Clinical Urinary Infectious Syndrome, A Potential Clinical Abdominal Infection Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 5 Jun 2020 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years of age presenting to the Timone 2 Emergency Department with the association
Key inclusion criteria (3 listed)
- Patient over 18 years of age presenting to the Timone 2 Emergency Department with the association:
Key exclusion criteria (9 listed)
- Patients with clinical criteria that may increase other non-specific biomarkers and therefore not allow for subsequent comparison:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Value of Flow Cytometry in Infectious Point of CareTo 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre MICHELET study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of A Potential Infectious Respiratory Clinical Syndrome and Potential Clinical Urinary Infectious Syndrome, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variables specifically measured for this study will be the flow cytometry assay of the two biomarkers (CD64, CD169) (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.