NCT03715569

Brief Summary

Study on patients with CNS infections.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 23, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

June 1, 2018

Last Update Submit

October 18, 2018

Conditions

CNS InfectionInner Ear Hearing LossVestibular AbnormalityInner Ear InflammationHearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

  • Cochlear damage

    Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.

    Day1-90

Secondary Outcomes (3)

  • Vestibular function loss

    Day 1-90

  • Identifying biochemical markers in CSF during a CNS infection

    Day 1-90

  • Cognitive impairment

    Day 90

Study Arms (5)

Cohort with CNS infections

Otoacoustic emissions (OAE), Wide Band Tympanometry (WBT), Vestibular function tests. Audiometry. MOCA, eGOS are cognitive tests. Biomarker is a protein found in the inner ear examined in the cerebral fluid.

Diagnostic Test: Vestibular functionDiagnostic Test: OAE/WBTDiagnostic Test: BiomarkerDiagnostic Test: MOCA, eGOSDiagnostic Test: Audiometry

OAE/WBT control: Healthy individuals

Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.

Diagnostic Test: OAE/WBT

OAE/WBT control: Systemic infection

Otoacoustic emission during admission

Diagnostic Test: OAE/WBT

OAE/WBT control: ICP changes

Otoacoustic emission on patients without an CNS infection before and after elective lumbare puncture with measurement of intracranial pressure (ICP).

Diagnostic Test: OAE/WBT

Biomarker control

Inner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation.

Diagnostic Test: Biomarker

Interventions

Vestibular functionDIAGNOSTIC_TEST

Vhit, Caloric test

Cohort with CNS infections
OAE/WBTDIAGNOSTIC_TEST

Oto acoustic emissions Wide Band Tympanometry

Cohort with CNS infectionsOAE/WBT control: Healthy individualsOAE/WBT control: ICP changesOAE/WBT control: Systemic infection
BiomarkerDIAGNOSTIC_TEST

Biomarker examination

Biomarker controlCohort with CNS infections
MOCA, eGOSDIAGNOSTIC_TEST

Cognitive tests

Cohort with CNS infections
AudiometryDIAGNOSTIC_TEST

Hearing test

Cohort with CNS infections

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the hospital with a CNS infection.

You may qualify if:

  • Patients with a CNS infection admitted to the hospital.

You may not qualify if:

  • Patients with known hearing loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillerød hospital

Hillerød, 3400, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebral fluid

MeSH Terms

Conditions

Central Nervous System InfectionsHearing Loss, SensorineuralLabyrinth Diseases

Interventions

Vestibular Function TestsEnvironmental BiomarkersAudiometry

Condition Hierarchy (Ancestors)

InfectionsCentral Nervous System DiseasesNervous System DiseasesHearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosisBiomarkersBiological FactorsBiological PhenomenaEnvironmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public HealthHearing Tests

Study Officials

  • Christian Brandt, MD

    Department of infectious diseases

    STUDY DIRECTOR

Central Study Contacts

Elisa Skovgaard Jensen, MD

CONTACT

+4530300969elisa.skovgaard.jensen@regionh.dk

Christian Brandt, MD

CONTACT

christian.thomas.brandt.01@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2018

First Posted

October 23, 2018

Study Start

December 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)