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

NCT06594133 | Completed DMC

• 1 other identifier: ES-2024-K144
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocardia Infections; Lung Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pulmonary Microbiota Diversity in Nocardia-infected Lung Transplant Recipients

  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 Outcomes (1)

• Correlation Between Pulmonary Microbiota and Clinical Outcomes

  January 2023 to August 2024

Study Arms (2)

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

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.

Interventions

Antibiotic Treatment DRUG

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.

Nocardia Pneumonia Group (NPG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhibin Xu: lead

Study Sites (1)

Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (5)

• Hemmersbach-Miller M, Catania J, Saullo JL. Updates on Nocardia Skin and Soft Tissue Infections in Solid Organ Transplantation. Curr Infect Dis Rep. 2019 Jun 21;21(8):27. doi: 10.1007/s11908-019-0684-7.

  PMID: 31227922 RESULT

• Fatahi-Bafghi M. Nocardiosis from 1888 to 2017. Microb Pathog. 2018 Jan;114:369-384. doi: 10.1016/j.micpath.2017.11.012. Epub 2017 Nov 13.

  PMID: 29146497 RESULT

• Restrepo A, Clark NM; Infectious Diseases Community of Practice of the American Society of Transplantation. Nocardia infections in solid organ transplantation: Guidelines from the Infectious Diseases Community of Practice of the American Society of Transplantation. Clin Transplant. 2019 Sep;33(9):e13509. doi: 10.1111/ctr.13509. Epub 2019 Mar 19.

  PMID: 30817024 RESULT

• Lebeaux D, Morelon E, Suarez F, Lanternier F, Scemla A, Frange P, Mainardi JL, Lecuit M, Lortholary O. Nocardiosis in transplant recipients. Eur J Clin Microbiol Infect Dis. 2014 May;33(5):689-702. doi: 10.1007/s10096-013-2015-5. Epub 2013 Nov 23.

  PMID: 24272063 RESULT

• Peleg AY, Husain S, Qureshi ZA, Silveira FP, Sarumi M, Shutt KA, Kwak EJ, Paterson DL. Risk factors, clinical characteristics, and outcome of Nocardia infection in organ transplant recipients: a matched case-control study. Clin Infect Dis. 2007 May 15;44(10):1307-14. doi: 10.1086/514340. Epub 2007 Apr 3.

  PMID: 17443467 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Bronchoalveolar lavage fluid (BALF) and blood samples collected from lung transplant recipients. These samples will be used for microbial community analysis and to assess the impact of Nocardia infection on pulmonary and systemic microbiota.

MeSH Terms

Conditions

Nocardia Infections

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Microbiology

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)