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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02841254
Other study ID # RC12_0102
Secondary ID
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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