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

NCT ID: NCT03798574

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2022-12-31

Brief 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.

Conditions

Meningococcal Infections; Neisseria Meningitis Sepsis; Neisseria Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

IMD Case

No intervention

No interventions assigned to this group

Control

No intervention

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Adelaide

OTHER

Sponsor Role: lead

Responsible Party

Helen Marshall

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Marshall

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Locations

The Children's Hospital at Westmead

Westmead, New South Wales, 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

Countries

Australia

References

Marshall H, McMillan M, Wang B, Booy R, Afzali H, Buttery J, Blyth CC, Richmond P, Shaw D, Gordon D, Barton B. AMEND study protocol: a case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults. BMJ Open. 2019 Dec 29;9(12):e032583. doi: 10.1136/bmjopen-2019-032583.

Reference Type: DERIVED

PMID: 31888931 (View on PubMed)

Other Identifiers

HREC/14/WCHN/024

Identifier Type: -

Identifier Source: org_study_id