Improving the Diagnosis of Pneumonia in Emergency Rooms

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Other: Nasopharyngeal Swab

• Study Type: Interventional
• Enrollment (Actual): 1364
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michel DRANCOURT, Pr; Phone Number: : 04 91 38 55 19; Email: michel.drancourt@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pneumonia Patients; Patient admitted at hospital with pneumonia, who need a microbiological diagnosis	Other: Nasopharyngeal Swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients in percentage with a confirmed etiological diagnosis of pneumonia	1 day

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2013
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimate): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Emergencies; Pneumonia
• Other Study ID Numbers: 2012-43 (Other Identifier: CCRRC); 2012-A01589-34 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No