Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies

NCT02841254 | Completed

• 1 other identifier: RC12_0102
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 3

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.

Conditions

Meningitis

Outcome Measures

Primary Outcomes (1)

• meningitis (either viral or bacterial) or absence of meningitis

  Until 2 days

Interventions

Non interventional study OTHER

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the Adults Emergency

You may qualify if:

• May be included in the study two groups of patients:
• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (3)

Châteaubriant Hospital

Châteaubriant, 44146, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Saint-nazaire Hospital

Saint-Nazaire, 44606, France

Location

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Cédric BRETONNIERE, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 22, 2016
• Study Start: November 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)