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

NCT03798574 | Completed

• 1 other identifier: HREC/14/WCHN/024
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 4

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. 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. 2.IMD imposes a significant financial burden upon individuals, families and society.
3. 3.Serogroup B disease is associated with an increased risk of sequelae when compared to non-B serogroup IMD.

Conditions

Meningococcal Infections; Neisseria Meningitis Sepsis; Neisseria Infection

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Difference in academic achievement between cases and controls.

  Between 2 to 10 years post IMD admission

• Difference in memory (verbal and visual) between cases and controls.

  Between 2 to 10 years post IMD admission

• Difference in executive functioning between cases and controls.

  Between 2 to 10 years post IMD admission

• Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire

  Between 2 to 10 years post IMD admission

• Difference in the frequency of psychiatric disorders between cases and controls.

  Between 2 to 10 years post IMD admission

Study Arms (2)

IMD Case

No intervention

Control

No intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth, and Sydney.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Adelaide: lead

Study Sites (4)

The Children's Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Women's and Children's Hosptial

Adelaide, South Australia, 5006, Australia

Location

Monash Children's Hospital, Melbourne

Clayton, Victoria, 3168, Australia

Location

Perth Children's Hospital

Nedlands, Western Australia, 6009, Australia

Location

Related Publications (1)

• 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.

  PMID: 31888931 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Helen Marshall

  University of Adelaide

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2018
• First Posted: January 10, 2019
• Study Start: March 1, 2016
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03

Locations

AU (4)