NCT02858661

Brief Summary

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of meningitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic 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 meningitis after POC test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

March 30, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
3.7 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

5.9 years

First QC Date

July 29, 2016

Last Update Submit

April 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients admitted with a meningitis with a confirmed etiological diagnosis

    1 day

Study Arms (1)

Patients diagnosed with clinical meningitis

EXPERIMENTAL

Patients admitted in emergency rooms for clinical meningitis, for which a nasopharyngeal swab will be performed in order to confirm the etiological diagnosis of meningitis

Other: Nasopharyngeal swab

Interventions

Patients diagnosed with clinical meningitis

Eligibility Criteria

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

You may qualify if:

  • Patient admitted at hospital for meningitis requiring, for the emergency physician, a microbiological examination with a "POC meningitis 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 patient 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

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System 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 29, 2016

First Posted

August 8, 2016

Study Start

March 30, 2013

Primary Completion

February 8, 2019

Study Completion

October 27, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations