Causes and Management of Aseptic Meningitis : A Retrospec... | NCT05586607

Studies
Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital

NCT05586607

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Dec 11, 2023Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Aseptic Meningitis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2021Actual

Primary Completion Date

Oct 20, 2021Actual

Completion Date

Dec 20, 2021Actual

First Submitted Date

Oct 14, 2022

First Submission Date that Met QC Criteria

Oct 18, 2022

First Posted Date

Oct 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2023

Last Update Posted Date

Dec 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The diagnostic and therapeutic management of patients with aseptic meningitis is a challenge for the practitioner. There are many etiologies of this condition (infectious, inflammatory, neoplastic, drug-induced), which it is necessary to know how to evoke and look for specifically.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective study of the etiologies of aseptic meningitis infection in Alsace		Files analysed retrospectively from January 01, 2015 to October 31, 2020 will be examined

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Major subject (≥18 years old)
Subject with aseptic meningitis (CSF pleocytosis, negative bacteriology) from January 2015 to October 2020, at HUS
Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research.

Exclusion criteria:

Subject who expressed their opposition to participating in the study
Subject under guardianship or curatorship
Subject under safeguard of justice
Positive VZV, HSV, or Enterovirus PCR in CSF
CSF analysis performed as part of the assessment of a known pathology
Traumatic or surgical etiology

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Major subject (≥18 years old) with aseptic meningitis (CSF pleocytosis, negative bacteriology) from January 2015 to October 2020, at HUS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Médecine interne et d'Immunologie Clinique - CHU de Strasbourg - France		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D008582	Meningitis, Aseptic
D003141	Communicable Diseases

Ancestor Terms

ID	Term
D008581	Meningitis
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided