Improving the Diagnosis of Pneumonia in Emergency Rooms
Primary Purpose
Pneumonia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasopharyngeal Swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Patient admitted at hospital for pneumonia requiring, for the emergency physician, a microbiological examination with a "POC pneumonia kit."
- Patient who has freely signed the informed written consent
- Patient affiliated to a social security scheme
Exclusion Criteria:
- Pregnant woman, parturient or nursing
- Adult major under guardianship
- Patient deprived of liberty under court order
- Patient refusing or unable to sign the informed consent form.
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pneumonia Patients
Arm Description
Patient admitted at hospital with pneumonia, who need a microbiological diagnosis
Outcomes
Primary Outcome Measures
Number of patients in percentage with a confirmed etiological diagnosis of pneumonia
Secondary Outcome Measures
Full Information
NCT ID
NCT02851771
First Posted
July 28, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02851771
Brief Title
Improving the Diagnosis of Pneumonia in Emergency Rooms
Official Title
Improving the Diagnosis of Pneumonia in Emergency Rooms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2013 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
October 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
5. Study Description
Brief Summary
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of pneumonia caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC tests Pneumonia. This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribo Nucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribo Nucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of pneumonia after POC tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pneumonia Patients
Arm Type
Experimental
Arm Description
Patient admitted at hospital with pneumonia, who need a microbiological diagnosis
Intervention Type
Other
Intervention Name(s)
Nasopharyngeal Swab
Primary Outcome Measure Information:
Title
Number of patients in percentage with a confirmed etiological diagnosis of pneumonia
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient admitted at hospital for pneumonia requiring, for the emergency physician, a microbiological examination with a "POC pneumonia kit."
Patient who has freely signed the informed written consent
Patient affiliated to a social security scheme
Exclusion Criteria:
Pregnant woman, parturient or nursing
Adult major under guardianship
Patient deprived of liberty under court order
Patient refusing or unable to sign the informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Learn more about this trial
Improving the Diagnosis of Pneumonia in Emergency Rooms
We'll reach out to this number within 24 hrs