Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies (MEDWATCH)

August 9, 2017 updated by: Nantes University Hospital

Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study

Meningitis are serious infections. Evidenced by high rates of mortality and sequelae. However, these diseases have a relatively small impact. Also physician services Home Emergencies they must be vigilant, alert, for clinical signs to be suspected meningitis. Indeed, it is only after this essential clinical milestone that will be carried out a lumbar puncture which will confirm the diagnosis and to quickly begin treatment.

Unfortunately, if recent studies can improve the therapeutic management of patients with meningitis, no study was interested in yet fundamental step of diagnosis.

It seems therefore necessary to achieve a prospective clinical study to reassess the adequacy of the clinical signs in the diagnosis of meningitis. The ideal would be to achieve a predictive clinical score of the presence or absence of meningitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Châteaubriant, France, 44146
        • Châteaubriant Hospital
      • Nantes, France, 44093
        • Nantes university hospital
      • Saint-Nazaire, France, 44606
        • Saint-Nazaire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients visiting the Adults Emergency

Description

Inclusion Criteria:

May be included in the study two groups of patients:

*On the one hand, those in which will be carried out a lumbar puncture. Ideally, all patients in whom the examination is envisaged will be included. The logistics must allow inclusion rate as high as possible (see below).

So, are included in this group, patients for which the following criteria are met:

  • Over 15 years patient and 3 months,
  • Admission to the emergency for less than 6 hours
  • Realization of a proposed lumbar puncture,
  • Information sheet given. *On the other hand, those in whom it is not intended to be carried by lumbar puncture, but for which the clinical picture present on admission makes relevant for clinical signs of meningitis.

So, are included in this group, patients for which the following criteria are met:

  • Over 15 years patient and 3 months,
  • Admission to the emergency for less than 6 hours

  • At least one of the following 5 clinical signs motivating consultation and / or present on admission:

    • fever (measured temperature above 38 ° C)
    • headache,
    • vomiting,
    • stiff neck,
    • vigilance disorders,
  • Information sheet given.

Exclusion Criteria:

  • Patient who underwent neurosurgery recent (within the month before admission).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
meningitis (either viral or bacterial) or absence of meningitis
Time Frame: Until 2 days
Until 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Cédric BRETONNIERE, Dr, Nantes university hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 19, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_0102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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