The All Ireland Infectious Diseases Cohort Project

NCT ID: NCT06410053

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2024-12-31

Brief Summary

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The All-Ireland Infectious Diseases (AIID) Cohort is a multicentre, prospective, longitudinal observational cohort that enrols consecutive adult subjects attending participating institutions for infectious disease services. This is an ongoing prospective observational cohort of unlimited duration.

Detailed Description

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The All-Ireland Infectious Diseases cohort study (AIID Cohort) is enrolling patients at a number of Irish Hospitals with infectious diseases, including Covid-19. The AIID Cohort is a multicentre, prospective, longitudinal, observational cohort that enrols consecutive adult subjects (\>18 years old) attending hospitals services for management of infections.

Subjects provide consent for use of routine clinical and laboratory data for research. All data is collected by a combination of retrospective medical note review and extraction of data from electronic health records. At a minimum, the following data items are to be collected at enrolment and subsequent clinic visits:

1. Demography and basic information (e.g. date of birth, gender, country of origin, ethnicity, anthropometric assessments, and reasons for the attendance, date or year for disease diagnosis and transmission risk.
2. Laboratory data: Relevant routine virological (including genotyping) and immunological data for characterisation of the HIV infection, TB, hepatitis C, COVID-19 and other relevant co-infections will also be collected as well as other relevant clinical routine data on tolerability and safety (i.e., renal, liver, lipids)
3. Medical treatment: All medications, including start-and stop dates and reason for discontinuation, adherence. Concomitant medical treatment related to co-infections and co-morbidities.
4. Clinical events: hospitalisation, diseases specific relevant active and previous diagnosis (e.g., AIDS and non-AIDS events, including comorbidities).

In addition, subjects are asked to provide biological samples for up to five occasions every six months for bio-banking for host profiling and pathogen bio-repository. To provide flexibility for participants around requirements for fasting or scheduling, participants may be asked to attend to provide samples for biobanking outside of routine scheduled clinic visits. These stored samples provide the opportunity for future research studies investigating host factors associated with the response to infection.

The AIID Cohort is approved by local institutional review boards and all participants provide written, informed consent. Data and samples within the AIID Cohort are accessed through standardised Data Access Guidelines and all approved Data Access Requests are approved by the local Ethics Committee.

Conditions

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Infectious Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years of age patients attending clinical services of participating institutions with issues related to infectious diseases.
* Willing and able to provide informed consent or
* Provide deferred assent if an incapacitated or unconscious patient is unable to provide informed consent

Exclusion Criteria

* Patients under 18 years of age
* Patients with learning disabilities, mental illness, or dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beaumont Hospital

OTHER

Sponsor Role collaborator

Children's Health Ireland

OTHER_GOV

Sponsor Role collaborator

Cork University Hospital

OTHER

Sponsor Role collaborator

Mater Misericordiae University Hospital

OTHER

Sponsor Role collaborator

Our Lady of Lourdes Hospital, Drogheda

OTHER_GOV

Sponsor Role collaborator

St. James's Hospital, Ireland

OTHER

Sponsor Role collaborator

St. Luke's Hospital, Ireland

OTHER

Sponsor Role collaborator

St Vincent's University Hospital, Ireland

OTHER

Sponsor Role collaborator

Wexford General Hospital

UNKNOWN

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Mallon, PhD, FRCPI

Role: PRINCIPAL_INVESTIGATOR

UCD

Locations

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Cork University Hospital

Cork, , Ireland

Site Status RECRUITING

Our Lady of Lourdes Hospital, Drogheda

Drogheda, , Ireland

Site Status RECRUITING

St Vincent's University Hospital, Ireland

Dublin, , Ireland

Site Status RECRUITING

Mater Misericordiae University Hospital

Dublin, , Ireland

Site Status RECRUITING

Beaumont Hospital

Dublin, , Ireland

Site Status RECRUITING

Children's Health Ireland at Crumlin

Dublin, , Ireland

Site Status RECRUITING

St James's Hospital

Dublin, , Ireland

Site Status RECRUITING

St Luke's General Hospital, Kilkenny

Kilkenny, , Ireland

Site Status RECRUITING

Wexford General Hospital

Wexford, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Aoife Cotter, PhD

Role: CONTACT

Alan Macken

Role: CONTACT

Facility Contacts

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Corina Sadlier, Dr

Role: primary

Justin Low, Dr

Role: primary

Eoin Feeney, Dr

Role: primary

Aoife Cotter, Dr

Role: primary

Alan Macken

Role: backup

Eoghan De Barra, Dr

Role: primary

Paddy Galvin, Dr

Role: primary

Fiona Lyons, Dr

Role: primary

Garry Courtney, Dr

Role: primary

Obada Yousef, Dr

Role: primary

Related Links

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Other Identifiers

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AIID Cohort

Identifier Type: -

Identifier Source: org_study_id

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