MEDWATCH: Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02841254

Collaborator

(none)

579

Enrollment

Locations

Actual Duration (Months)

193

Patients Per Site

10.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Meningitis	Other: Non interventional study

Study Design

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 :

Nov 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Outcome Measures

Primary Outcome Measures

meningitis (either viral or bacterial) or absence of meningitis [Until 2 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Châteaubriant Hospital	Châteaubriant	France	44146
2	Nantes University Hospital	Nantes	France	44093
3	Saint-nazaire Hospital	Saint-Nazaire	France	44606

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator: Cédric BRETONNIERE, Dr, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nantes University Hospital

ClinicalTrials.gov Identifier:

NCT02841254

Other Study ID Numbers:

RC12_0102

First Posted:

Jul 22, 2016

Last Update Posted:

Aug 11, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Meningitis

Emergencies

Study Results

No Results Posted as of Aug 11, 2017