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

November 11, 2024 updated by: Zhibin Xu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study includes lung transplant recipients treated at Guangzhou Medical University First Affiliated Hospital from January 2023 to August 2024, including patients diagnosed with Nocardia pneumonia and matched non-infected controls.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nocardia Pneumonia Group (NPG)
This group consists of lung transplant recipients diagnosed with Nocardia pneumonia. The patients in this group are studied to assess the impact of Nocardia infection on the pulmonary microbiota. Samples including bronchoalveolar lavage fluid (BALF) and blood are collected for microbial community analysis.
Drug: Antibiotic Treatment

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.
Non-Nocardia Infection Group (NNIG)
This group consists of lung transplant recipients who are not infected with Nocardia. These patients serve as the control group and are matched with the Nocardia pneumonia group based on clinical characteristics such as age, sex, and underlying conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Microbiota Diversity in Nocardia-infected Lung Transplant Recipients
Time Frame: January 2023 to August 2024
Measurement 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.
January 2023 to August 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Pulmonary Microbiota and Clinical Outcomes
Time Frame: January 2023 to August 2024
Correlation 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.
January 2023 to August 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhibin Xu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 11, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ES-2024-K144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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