NCT Number: NCT02841254
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies
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.
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Notify MeKey information
Age range
15 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Châteaubriant Hospital, Châteaubriant, France
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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).
Treatment and study plan
Primary outcomes
-
meningitis (either viral or bacterial) or absence of meningitis
Time frame: Until 2 days
Sponsors and collaborators
Lead sponsor
Nantes University Hospital
Other
Registry information
Official study title
Diagnostic Performance of Clinical Signs Patients Suspected of Meningitis to Emergencies. Prospective and Multicentric Study
Acronym: MEDWATCH
Important dates
- Study start
- 2014
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 22, 2016
- Registry last updated
- Aug 11, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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