The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

Meningococcal Infections Clinical Trial

— AMEND  

Official title:

The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798574
• Other study ID #: HREC/14/WCHN/024
• Status: Completed
• Start date: March 1, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Survivors of invasive meningococcal disease (IMD) experience a range of mild to severe sequelae that impact upon their quality of life. The majority of studies to date have focused on the impact of IMD on childhood and very little is known about the impact of the disease on adolescents and young people.

The aim of this study is to assess the physical, neurocognitive, economic and societal impact of IMD on adolescents and young adult Australian survivors.

Hypothesis:

1. Adolescents and young adult survivors who are 2 to 10 years post IMD have significantly poorer outcomes including intellectual functioning and quality of life when compared to healthy controls.

2. IMD imposes a significant financial burden upon individuals, families and society.

3. Serogroup B disease is associated with an increased risk of sequelae when compared to non-B serogroup IMD.

Study design:

This a multi-centre, case-control mixed-methods study. Survivors of IMD (retrospective and prospective cases) and non-IMD healthy controls will be invited to participate in the study.

Retrospective IMD cases admitted in the previous 10 years will be identified through each of the participating hospitals (paediatric and adult hospitals). During the course of the study prospective recruitment of IMD cases will also occur at participating hospitals. Meningococcal foundations/groups will also be approached and asked to advertise and conduct a mail out to their members to inform them about the study.

Healthy controls will be prospectively recruited by "snowballing technique" whereby enrolled IMD cases will be asked to distribute a study information sheet to their healthy friends/acquaintances who are approximately the same age. Control participants may also be identified from databases at each participating site or through community advertising.

Enrolled cases will undergo a neurocognitive, psychological and physical examination 2 - 10 years post IMD admission. A subset of IMD cases will be invited to participate in a semi-structured interview. Controls will also undergo neurocognitive, psychological and physical examination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• Patients aged 15 to 24 years 11 months at time of IMD admission

• Hospitalised IMD case from 1st January 2006 -with serogroup B or non-B IMD, confirmed by culture or polymerase chain reaction (PCR) in blood or CSF.

• Healthy controls aged 17 to 34 years 11 months at the time of assessment.

Exclusion Criteria:

• Individuals who are not fluent with the English language.

• Control participants with a history of meningitis, encephalitis, or meningococcal disease, intellectual disability, intracranial pathology (eg. traumatic brain injury) that may impact on cognitive functioning, or significant vision and/or hearing loss that may impact on the validity or reliability of the neurocognitive assessment.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Meningitis
• Meningococcal Infections
• Neisseria Infection
• Neisseria Meningitis Sepsis

Locations

Country	Name	City	State
Australia	Women's and Children's Hosptial	Adelaide	South Australia
Australia	Monash Children's Hospital, Melbourne	Clayton	Victoria
Australia	Perth Children's Hospital	Nedlands	Western Australia
Australia	The Children's Hospital at Westmead	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in intellectual functioning between cases and controls	Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)	Between 2 to 10 years post IMD admission
Primary	Difference in quality of life between cases and controls	Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.	Between 2 to 10 years post IMD admission
Secondary	Difference in academic achievement between cases and controls.	Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)	Between 2 to 10 years post IMD admission
Secondary	Difference in memory (verbal and visual) between cases and controls.	Measured by Verbal Learning and Design Memory subtests from the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2)	Between 2 to 10 years post IMD admission
Secondary	Difference in executive functioning between cases and controls.	Measured by Delis-Kaplan Executive Function System (D-KEFS)	Between 2 to 10 years post IMD admission
Secondary	Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire	Assessed through BRIEF self-report questionnaire (parent and/or self-report)	Between 2 to 10 years post IMD admission
Secondary	Difference in the frequency of psychiatric disorders between cases and controls.	Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)	Between 2 to 10 years post IMD admission
Secondary	Difference in psychological functioning between cases and controls.	Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)	Between 2 to 10 years post IMD admission
Secondary	Difference in behavioral ratings between cases and controls	Measured by Conners Rating Scales (parent and/or self-report)	Between 2 to 10 years post IMD admission
Secondary	Difference in health and disability functioning between cases and controls	Measured by the International Classification of Functioning, Disability and Health (ICF) tool.	Between 2 to 10 years post IMD admission
Secondary	Difference in hearing threshold levels between cases and controls	Measured by pure tone audiometry.	Between 2 to 10 years post IMD admission
Secondary	Difference in health status between cases and controls	The EQ-5D-5L will be completed to measure participant's health status and to calculate quality adjusted life years (QALYS) lost.	Between 2 to 10 years post IMD admission
Secondary	To estimate the lifetime costs associated with survival following IMD	IMD cases only: Lifetime dollar costs.	From time of admission up to time of follow up (2 to 10 years post IMD admission)
Secondary	Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD	A subset of IMD cases will participate in a semi-structured interview.	Between 2 to 10 years post IMD admission
Secondary	Carer's experience assessed through the Carer Experience Scale	For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete the Carer Experience Scale.	Between 2 to 10 years post IMD admission
Secondary	Carer's experience assessed through ICEpop CAPability questionnaires	For those IMD cases with a disability, the primary caregiver and other family members living in the same household will be invited to complete ICEpop CAPability questionnaire.	Between 2 to 10 years post IMD admission