Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia
NCT ID: NCT06594133
Last Updated: 2024-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
68 participants
OBSERVATIONAL
2023-01-01
2024-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Nocardia pneumonia (for the study group)
* Age ≥ 18 years
Exclusion Criteria
* Patients who survived ≤ 3 days after transplantation
* Patients lost to follow-up
18 Years
ALL
No
Sponsors
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Zhibin Xu
OTHER
Responsible Party
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Zhibin Xu
Professor of Microbiology
Locations
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Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ES-2024-K144
Identifier Type: -
Identifier Source: org_study_id
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