Meningococcal InfectionsAMENDNCT03798574
The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
An observational study of Meningococcal Infections and Neisseria Meningitis Sepsis, run by University of Adelaide at 4 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections, Neisseria Meningitis Sepsis, Neisseria Infection
- How many people
- 98 participants
- Where
- 4 sitesAustralia
- Study dates
- 1 Mar 2016to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth, and Sydney.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Women's and Children's Hosptial
Adelaide, South Australia, 5006
Monash Children's Hospital, Melbourne
Clayton, Victoria, 3168
Perth Children's Hospital
Nedlands, Western Australia, 6009
The Children's Hospital at Westmead
Westmead, New South Wales, 2145
About this study
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.
Read more
Hypothesis:
- 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.
- IMD imposes a significant financial burden upon individuals, families and society.
- 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.
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IMD Case | No intervention | |
| Control | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Between 2 to 10 years post IMD admission
Secondary outcomes (14)
Difference in academic achievement between cases and controls.
Measured by Wechsler Individual Achievement Test - Second Edition (WIAT-II)
Measured: Between 2 to 10 years post IMD admission
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)
Measured: Between 2 to 10 years post IMD admission
Difference in executive functioning between cases and controls.
Measured by Delis-Kaplan Executive Function System (D-KEFS)
Measured: Between 2 to 10 years post IMD admission
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)
Measured: Between 2 to 10 years post IMD admission
Difference in the frequency of psychiatric disorders between cases and controls.
Assessed through Mini International Neuropsychiatric Interview (M.I.N.I 6.0)
Measured: Between 2 to 10 years post IMD admission
Difference in psychological functioning between cases and controls.
Assessed through self report questionnaire Depression Anxiety Stress Scales (DASS) (self-report)
Measured: Between 2 to 10 years post IMD admission
Difference in behavioral ratings between cases and controls
Measured by Conners Rating Scales (parent and/or self-report)
Measured: Between 2 to 10 years post IMD admission
Difference in health and disability functioning between cases and controls
Measured by the International Classification of Functioning, Disability and Health (ICF) tool.
Measured: Between 2 to 10 years post IMD admission
Difference in hearing threshold levels between cases and controls
Measured by pure tone audiometry.
Measured: Between 2 to 10 years post IMD admission
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.
Measured: Between 2 to 10 years post IMD admission
To estimate the lifetime costs associated with survival following IMD
IMD cases only: Lifetime dollar costs.
Measured: From time of admission up to time of follow up (2 to 10 years post IMD admission)
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.
Measured: Between 2 to 10 years post IMD admission
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.
Measured: Between 2 to 10 years post IMD admission
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.
Measured: Between 2 to 10 years post IMD admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Mar 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Meningococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Marshall, University of Adelaide
- Investigators
- Helen Marshall, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798574
- Sponsor's protocol ID
- HREC/14/WCHN/024
- Acronym
- AMEND
- Status last verified
- Mar 2023
- First submitted
- 23 Dec 2018
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McMillan M, Mohammed H, Buttery J, Angliss M, Barton B, Blyth CC, Mathew SM, Warner MS, Nelson R, Hannah R, Runnegar N, Marshall HS. Delayed diagnosis is associated with complications following invasive meningococcal disease in Australian adolescents and young adults. Infection. 2026 May 18. doi: 10.1007/s15010-026-02827-6. Online ahead of print.
PubMed 42149359Marshall 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.
PubMed 31888931
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long-term Impact of Invasive Meningococcal Disease in Australian Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT03798574
- Acronym / sponsor ID
- AMEND / HREC/14/WCHN/024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- IMD imposes a significant financial burden upon individuals, families and society.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMD Case | – | –No intervention |
| Control | – | –No intervention |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Population sample from participating Australian hospitals in Adelaide, Melbourne, Perth, and Sydney.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in intellectual functioning between cases and controls
Time frame: Between 2 to 10 years post IMD admission
Measured by the Full Scale intelligence quotient (IQ) score obtained from the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV)
Difference in quality of life between cases and controls
Time frame: Between 2 to 10 years post IMD admission
Measured by the overall multi-attribute health utility score obtained from the Health Utilities Index Mark 3 (HUI3)-15Q self-report.
14 secondary outcomes
Difference in academic achievement between cases and controls.
Time frame: Between 2 to 10 years post IMD admission
Difference in memory (verbal and visual) between cases and controls.
Time frame: Between 2 to 10 years post IMD admission
Difference in executive functioning between cases and controls.
Time frame: Between 2 to 10 years post IMD admission
Difference in executive functioning between cases and controls assessed through BRIEF self-report questionnaire
Time frame: Between 2 to 10 years post IMD admission
Difference in the frequency of psychiatric disorders between cases and controls.
Time frame: Between 2 to 10 years post IMD admission
Difference in psychological functioning between cases and controls.
Time frame: Between 2 to 10 years post IMD admission
Difference in behavioral ratings between cases and controls
Time frame: Between 2 to 10 years post IMD admission
Difference in health and disability functioning between cases and controls
Time frame: Between 2 to 10 years post IMD admission
Difference in hearing threshold levels between cases and controls
Time frame: Between 2 to 10 years post IMD admission
Difference in health status between cases and controls
Time frame: Between 2 to 10 years post IMD admission
To estimate the lifetime costs associated with survival following IMD
Time frame: From time of admission up to time of follow up (2 to 10 years post IMD admission)
Explore adolescents and young people's experience of their hospital presentation, admission, and recovery from IMD
Time frame: Between 2 to 10 years post IMD admission
Carer's experience assessed through the Carer Experience Scale
Time frame: Between 2 to 10 years post IMD admission
Carer's experience assessed through ICEpop CAPability questionnaires
Time frame: Between 2 to 10 years post IMD admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Derived from this study: PubMed 42149359McMillan M, Mohammed H, Buttery J, Angliss M, Barton B, Blyth CC, Mathew SM, Warner MS, Nelson R, Hannah R, Runnegar N, Marshall HS. Delayed diagnosis is associated with complications following invasive meningococcal disease in Australian adolescents and young adults. Infection. 2026 May 18. doi: 10.1007/s15010-026-02827-6. Online ahead of print.
- Derived from this study: PubMed 31888931Marshall 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Marshall principal investigator
University of Adelaide
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningococcal Infections and Neisseria Meningitis Sepsis, run by University of Adelaide at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in intellectual functioning between cases and controls (time frame: Between 2 to 10 years post IMD admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798574, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.