Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies

Meningitis Clinical Trial

— MEDWATCH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841254
• Other study ID #: RC12_0102
• Status: Completed
• Phase: N/A
• First received: July 19, 2016
• Last updated: August 9, 2017
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Emergencies
• Meningitis

Intervention

Other:
• Non interventional study

Locations

Country	Name	City	State
France	Châteaubriant Hospital	Châteaubriant
France	Nantes University Hospital	Nantes
France	Saint-nazaire Hospital	Saint-Nazaire

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	meningitis (either viral or bacterial) or absence of meningitis		Until 2 days