Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410053
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-04-05
Brief Title:
The All Ireland Infectious Diseases Cohort Project
Sponsor:
University College Dublin
Organization:
University College Dublin
Study Overview
Official Title:
The All Ireland Infectious Diseases Cohort Project - AIID Cohort Project
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AIID
Brief 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
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 eg 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 ie 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 eg 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
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 eg 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 ie 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None