Meningitis sequelae in Adulthood: Towards and Understanding of Residual Effects after childhood bacterial infectio

Not yet recruiting

• Conditions: infection of the meninges; Meningitis; 10004018

• Registration Number: NL-OMON56904
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 184

Inclusion Criteria

Childhood bacterial meningitis survivors:
1. History of childhood bacterial meningitis;
2. 18 years of age or older;
3. Fluent Dutch speaker.

Control group:
1. 21 years of age or older;
2. Fluent Dutch speaker;
3. No documented diagnosis of a neurological disorder (among which meningitis).

Exclusion Criteria

1. Absence or withdrawal of written informed consent;
2. *Complex onset* of meningitis, defined as: meningitis secondary to
immunodeficiency states, central nervous system surgery, cranial trauma or
cerebrospinal fluid shunt infections or relapsing meningitis;
3. Somatic disorders unrelated to meningitis, congenital disorders, and severe
motor or sensory disabilities that interfere with outcome assessment at time of
assessment;
4. Inability to comprehend testing instructions at time of assessment.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters will be 1) neurocognitive outcome as measured by the Emma<br /><br>Toolbox (an in-depth measure of neurocognitive functioning that was developed<br /><br>in-house) and a short form of the Wechsler Adult Intelligence Scale IV<br /><br>(WAIS-IV) estimating Full Scale IQ, 2) behavioral and emotional functioning as<br /><br>measured by the Adult Self Report (ASR) and Post-traumatic Stress Disorder<br /><br>Checklist for DSM-5 (PCL-5), 3) Health related quality of life as measured by<br /><br>the Patient Reported Outcomes Measurement Information System (PROMIS) 29+2<br /><br>Profile and the EuroQoL EQ-5D-5L, 4) Participation in society as measured by<br /><br>the PROMIS Ability to Participate in Social Roles and Activities (PROMIS APS)<br /><br>short form 8a and a custom participation questionnaire, and 5) hearing as<br /><br>measured by the Amsterdam Inventory for Auditory Disability and Handicap<br /><br>(AIADH).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters will be brain structure and functioning (MRI<br /><br>scanning)</p><br>