MedTrace Logo

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

NCT03798574 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2023-03-09

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Adelaide

    lead OTHER

Principal Investigators

  • Helen Marshall · University of Adelaide

Eligibility

Min Age
15 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798574 on ClinicalTrials.gov