Clinical trial NCT02841254: Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies
Official title: Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 579
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients visiting the Adults Emergency

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.


Eligibility 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).

Primary outcomes:
measure: meningitis (either viral or bacterial) or absence of meningitis
timeFrame: Until 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Châteaubriant
country: France
facility: Châteaubriant Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Saint-Nazaire
country: France
facility: Saint-nazaire Hospital
Study officials:
affiliation: Nantes University Hospital
name: Cédric BRETONNIERE, Dr
role: PRINCIPAL_INVESTIGATOR
References: