NCT02851771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2013

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

5.8 years

First QC Date

July 28, 2016

Last Update Submit

April 20, 2023

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Number of patients in percentage with a confirmed etiological diagnosis of pneumonia

    1 day

Study Arms (1)

Pneumonia Patients

EXPERIMENTAL

Patient admitted at hospital with pneumonia, who need a microbiological diagnosis

Other: Nasopharyngeal Swab

Interventions

Nasopharyngeal SwabOTHER
Pneumonia Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Catherine GEINDRE

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 2, 2016

Study Start

June 14, 2013

Primary Completion

April 15, 2019

Study Completion

October 27, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

FR(1)