Viewing Study NCT04397861



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Study NCT ID: NCT04397861
Status: COMPLETED
Last Update Posted: 2022-09-29
First Post: 2020-05-18

Brief Title: T Cell Memory Fuels the Innate Response in Chronic CF Lung Disease
Sponsor: National Jewish Health
Organization: National Jewish Health

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2022-09
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: None
Brief Summary: This study seeks to define the role of CD4 and CD8 T cell memory responses in the immunologic failure of patients with cystic fibrosis CF to clear infections In a normal host the immune system clears pathogens upon re-infection more swiftly and efficiently than during an initial infection in great part due to the recall and effector functions of memory T cells In CF far less is understood regarding the response of T cell memory when hosts reencounter antigens otherwise known as pulmonary exacerbations Pulmonary exacerbations are pivotal events that lead to a decline in health status among CF patients with many never recovering to baseline health CF patients will be recruited from patients followed by the Adult CF Program at National Jewish Health Following enrollment at the time of antibiotic initiation blood will be collected at two different time points The first samples will be collected within 24 hours of starting IV antibiotic therapy The second blood specimen will be collected at the end of hospitalization after a minimum of 5 days At the time of each blood draw complete blood counts a sputum sample and simple spirometry will be measured as part of the standard care of a CF exacerbation Isolated PBMCs will be stained with antibodies to designate cell surface phenotype They will then be sorted to identify the T cell population These cells will be tested on their ability to clear pathogens The relationship between cellular immune responses and clinical indicators of pulmonary status will be examined by fitting linear mixed models
Detailed Description: None

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