The All Ireland Infectious Diseases Cohort Project (AIID)

The All Ireland Infectious Diseases Cohort Project - AIID Cohort Project

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.

Study Overview

• Status: Recruiting
• Conditions: Infectious Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Aoife Cotter, PhD; Email: aoife.cotter@ucd.ie
• Study Contact Backup: Name: Alan Macken; Email: alan.macken@ucd.ie

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • Cork University Hospital
    • Contact: Corina Sadlier, Dr
  • Drogheda, Ireland
    • Recruiting
    • Our Lady of Lourdes Hospital, Drogheda
    • Contact: Justin Low, Dr
  • Dublin, Ireland, Dublin 7
    • Recruiting
    • Mater Misericordiae University Hospital
    • Contact: Aoife Cotter, Dr
    • Contact: Alan Macken
  • Dublin, Ireland
    • Recruiting
    • Beaumont Hospital
    • Contact: Eoghan De Barra, Dr
  • Dublin, Ireland
    • Recruiting
    • Children's Health Ireland at Crumlin
    • Contact: Paddy Galvin, Dr
  • Dublin, Ireland
    • Recruiting
    • St James's Hospital
    • Contact: Fiona Lyons, Dr
  • Dublin, Ireland, D4
    • Recruiting
    • St Vincent's University Hospital, Ireland
    • Contact: Eoin Feeney, Dr
  • Kilkenny, Ireland
    • Recruiting
    • St Luke's General Hospital, Kilkenny
    • Contact: Garry Courtney, Dr
  • Wexford, Ireland
    • Recruiting
    • Wexford General Hospital
    • Contact: Obada Yousef, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients attending Clinical Services relating to infectious diseases at participating hospitals in Ireland who provide written informed consent.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of data rich cohort	Overall number of recruited participants and number of recruited participants with major conditions (COVID-19, HIV, TB)	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort retention	Number of subjects in care or mortality	through study completion, an average of 1 year
Cohort associated metadata	Number of subjects recruited to the cohort with completed metadata and biobanked samples	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University College Dublin
• Collaborators: St Vincent's University Hospital, Ireland; Mater Misericordiae University Hospital; St. James's Hospital, Ireland; Cork University Hospital; Beaumont Hospital; Our Lady of Lourdes Hospital, Drogheda; Children's Health Ireland; St. Luke's Hospital, Ireland; Wexford General Hospital
• Investigators: Principal Investigator: Patrick Mallon, PhD, FRCPI, UCD

Publications and helpful links

Helpful Links

• AIID Cohort Project

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: COVID-19; Human Immunodeficiency virus; Bone infection; Viral hepatitis; Skin and soft tissue infections
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: AIID Cohort

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No