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Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia

Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia: A Single-center Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06594133
Acronym
NocardiaLM
Enrollment
68
Registered
2024-09-19
Start date
2023-01-01
Completion date
2024-09-01
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocardia Infections, Lung Transplantation

Keywords

Nocardia;, Pulmonary Microbiota;, Retrospective Study;, Immunosuppression

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.

Interventions

For lung transplant recipients with Nocardia infection, the treatment regimen could include: Sulfamethoxazole/Trimethoprim (Bactrim): 800 mg/160 mg orally or intravenously twice daily for at least 6 months. Imipenem: 500 mg intravenously every 6 hours for severe cases. Monitoring: Regular monitoring of blood levels of the drug to avoid toxicity and adjust doses accordingly.

Sponsors

Zhibin Xu
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Lung transplant recipients * Diagnosed with Nocardia pneumonia (for the study group) * Age ≥ 18 years

Exclusion criteria

* Patients with incomplete medical records * Patients who survived ≤ 3 days after transplantation * Patients lost to follow-up

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary Microbiota Diversity in Nocardia-infected Lung Transplant RecipientsJanuary 2023 to August 2024Measurement of alpha and beta diversity of the pulmonary microbiota in BALF samples from lung transplant recipients with and without Nocardia infection. Alpha diversity will be quantified using Shannon diversity index and observed species richness, while beta diversity will be analyzed using Bray-Curtis dissimilarity. Microbial composition and relative abundance will be compared between the Nocardia pneumonia group and the non-Nocardia infection group. Changes in diversity metrics will be analyzed over time to assess the impact of Nocardia infection on pulmonary microbiota.

Secondary

MeasureTime frameDescription
Correlation Between Pulmonary Microbiota and Clinical OutcomesJanuary 2023 to August 2024Correlation between pulmonary microbiota diversity and clinical factors such as age, kidney function, nutritional status, and immunosuppressive therapy in lung transplant recipients. The analysis includes changes in pulmonary microbiota before and after treatment in patients with Nocardia infection and the number of participants showing significant correlations between microbiota diversity and clinical outcomes.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026