The All Ireland Infectious Diseases Cohort Project

Infectious Disease Clinical Trial

— AIID  

Official title:

The All Ireland Infectious Diseases Cohort Project - AIID Cohort Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410053
• Other study ID #: AIID Cohort
• Status: Recruiting
• Start date: March 2011
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University College Dublin
• Contact: Aoife Cotter, PhD
• Email: aoife.cotter[@]ucd.ie
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork
Ireland	Our Lady of Lourdes Hospital, Drogheda	Drogheda
Ireland	Beaumont Hospital	Dublin
Ireland	Children's Health Ireland at Crumlin	Dublin
Ireland	Mater Misericordiae University Hospital	Dublin
Ireland	St James's Hospital	Dublin
Ireland	St Vincent's University Hospital, Ireland	Dublin
Ireland	St Luke's General Hospital, Kilkenny	Kilkenny
Ireland	Wexford General Hospital	Wexford

Sponsors (10)

Lead Sponsor	Collaborator
University College Dublin	Beaumont Hospital, Children's Health Ireland, Cork University Hospital, Mater Misericordiae University Hospital, Our Lady of Lourdes Hospital, Drogheda, St Vincent's University Hospital, Ireland, St. James's Hospital, Ireland, St. Luke's Hospital, Ireland, Wexford General Hospital

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cohort retention	Number of subjects in care or mortality	through study completion, an average of 1 year
Secondary	Cohort associated metadata	Number of subjects recruited to the cohort with completed metadata and biobanked samples	through study completion, an average of 1 year

External Links

•   AIID Cohort Project