Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594133
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia A Single-center Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NocardiaLM
Brief Summary:
This retrospective observational study aims to explore the impact of Nocardia infection on the pulmonary microbiota of lung transplant recipients LTRs The study will analyze both cross-sectional and longitudinal data from patients diagnosed with Nocardia pneumonia comparing microbial composition and diversity between infected and non-infected groups This research seeks to provide insights into the relationship between pulmonary microbiota alterations and clinical outcomes in LTRs
Detailed Description:
This study is a single-center retrospective observational study designed to investigate the impact of Nocardia infection on the pulmonary microbiota of lung transplant recipients LTRs The study will include both cross-sectional and longitudinal analyses In the cross-sectional study 17 LTRs diagnosed with Nocardia pneumonia Nocardia pneumonia group NPG will be compared with 51 non-infected LTRs non-Nocardia infection group NNIG matched for age sex and underlying conditions
The longitudinal study will follow LTRs over a 4-month period collecting samples before during and after treatment Patients in this group will be categorized into the Recovered group RG or Not Recovered group NRG based on treatment outcomes The study will also include a subgroup analysis of patients with disseminated Nocardia infection comparing pulmonary and systemic microbiota changes
Microbial diversity and composition will be assessed using high-throughput sequencing of bronchoalveolar lavage fluid BALF samples Statistical analyses will include the Kolmogorov-Smirnov test ANOVA and Kruskal-Wallis test for group comparisons with linear mixed-effects models used to analyze changes over time
The goal of this study is to provide a deeper understanding of how Nocardia infection affects the pulmonary microbiota in LTRs and to identify key microbial species associated with clinical outcomes
The longitudinal study will follow LTRs over a 4-month period collecting samples before during and after treatment Patients in this group will be categorized into the Recovered group RG or Not Recovered group NRG based on treatment outcomes The study will also include a subgroup analysis of patients with disseminated Nocardia infection comparing pulmonary and systemic microbiota changes
Microbial diversity and composition will be assessed using high-throughput sequencing of bronchoalveolar lavage fluid BALF samples Statistical analyses will include the Kolmogorov-Smirnov test ANOVA and Kruskal-Wallis test for group comparisons with linear mixed-effects models used to analyze changes over time
The goal of this study is to provide a deeper understanding of how Nocardia infection affects the pulmonary microbiota in LTRs and to identify key microbial species associated with clinical outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None