Infectious DiseaseAIIDNCT06410053
The All Ireland Infectious Diseases Cohort Project
An observational study of Infectious Disease, run by University College Dublin at 9 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infectious Disease
- How many people
- 10,000 participants
- Where
- 9 sitesIreland
- Study dates
- Mar 2011to Dec 2024
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients attending Clinical Services relating to infectious diseases at participating hospitals in Ireland who provide written informed consent.
Who may be able to join
- ≥ 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
Who cannot join
- Patients under 18 years of age
- Patients with learning disabilities, mental illness, or dementia
Trial locations and contacts
9 sites in 1 country.
Aoife Cotter, PhD contact
Alan Macken contact
9 sites in 1 country
Ireland9 sites, 9 recruiting
- Recruiting
Cork University Hospital
Cork
Corina Sadlier, Dr
- Recruiting
Our Lady of Lourdes Hospital, Drogheda
Drogheda
Justin Low, Dr
- Recruiting
St Vincent's University Hospital, Ireland
Dublin, D4
Eoin Feeney, Dr
- Recruiting
Mater Misericordiae University Hospital
Dublin, Dublin 7
Aoife Cotter, Dr
Alan Macken
- Recruiting
Beaumont Hospital
Dublin
Eoghan De Barra, Dr
- Recruiting
Children's Health Ireland at Crumlin
Dublin
Paddy Galvin, Dr
- Recruiting
St James's Hospital
Dublin
Fiona Lyons, Dr
- Recruiting
St Luke's General Hospital, Kilkenny
Kilkenny
Garry Courtney, Dr
- Recruiting
Wexford General Hospital
Wexford
Obada Yousef, Dr
About this study
Official title: 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.
Read the 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:
- 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.
- 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)
- Medical treatment: All medications, including start-and stop dates and reason for discontinuation, adherence. Concomitant medical treatment related to co-infections and co-morbidities.
- 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
- Infectious Disease
- Keywords
- Human Immunodeficiency virus, COVID-19, Viral hepatitis, Skin and soft tissue infections, Bone infection
- Medical subject headings
- Communicable Diseases, Acquired Immunodeficiency Syndrome, COVID-19, Soft Tissue Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Establishment of data rich cohort
Overall number of recruited participants and number of recruited participants with major conditions (COVID-19, HIV, TB)
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Cohort retention
Number of subjects in care or mortality
Measured: through study completion, an average of 1 year
Cohort associated metadata
Number of subjects recruited to the cohort with completed metadata and biobanked samples
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study startMar 2011
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Beaumont Hospital, Children's Health Ireland, Cork University Hospital, Mater Misericordiae University Hospital, Our Lady of Lourdes Hospital, Drogheda, St. James's Hospital, Ireland, St. Luke's Hospital, Ireland, St Vincent's University Hospital, Ireland, Wexford General Hospital
- Responsible party
- Sponsor
- Investigators
- Patrick Mallon, PhD, FRCPI, Principal investigator, UCD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410053
- Sponsor's protocol ID
- AIID Cohort
- Acronym
- AIID
- Status last verified
- May 2024
- First submitted
- 5 Apr 2023
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The All Ireland Infectious Diseases Cohort Project - AIID Cohort Project
- ClinicalTrials.gov ID
- NCT06410053
- Acronym / sponsor ID
- AIID / AIID Cohort
- Conditions
- Infectious Disease
- Keywords
- Human Immunodeficiency virus, COVID-19, Viral hepatitis, Skin and soft tissue infections, Bone infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Beaumont Hospital, Children's Health Ireland, Cork University Hospital, Mater Misericordiae University Hospital, Our Lady of Lourdes Hospital, Drogheda, St. James's Hospital, Ireland, St. Luke's Hospital, Ireland, St Vincent's University Hospital, Ireland, Wexford General Hospital
- Study start
- Mar 2011 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 May 2024 (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.
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
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:
- 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.
- 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)
- Medical treatment: All medications, including start-and stop dates and reason for discontinuation, adherence. Concomitant medical treatment related to co-infections and co-morbidities.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients attending Clinical Services relating to infectious diseases at participating hospitals in Ireland who provide written informed consent.
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients with learning disabilities, mental illness, or dementia
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
Establishment of data rich cohort
Time frame: through study completion, an average of 1 year
Overall number of recruited participants and number of recruited participants with major conditions (COVID-19, HIV, TB)
2 secondary outcomes
Cohort retention
Time frame: through study completion, an average of 1 year
Cohort associated metadata
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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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.
Aoife Cotter, PhD contact
Alan Macken contact
Patrick Mallon, PhD, FRCPI principal investigator
UCD
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease, run by University College Dublin at 9 sites in Ireland.
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: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aoife Cotter, PhD (aoife.cotter@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establishment of data rich cohort (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2024.