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Trial record 7 of 578 for:    meningitis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02841254
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : August 11, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Meningitis Other: Non interventional study

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Study Type : Observational
Actual Enrollment : 579 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study
Actual Study Start Date : November 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis




Primary Outcome Measures :
  1. meningitis (either viral or bacterial) or absence of meningitis [ Time Frame: Until 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients visiting the Adults Emergency
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841254


Locations
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France
Châteaubriant Hospital
Châteaubriant, France, 44146
Nantes University Hospital
Nantes, France, 44093
Saint-nazaire Hospital
Saint-Nazaire, France, 44606
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Cédric BRETONNIERE, Dr Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02841254     History of Changes
Other Study ID Numbers: RC12_0102
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Emergencies
Meningitis
Disease Attributes
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases