Nocardia InfectionsNocardiaLMNCT06594133
Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia
An observational study of Nocardia Infections and Lung Transplantation, run by Zhibin Xu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocardia Infections, Lung Transplantation
- What is being tested?
- Antibiotic Treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Lung transplant recipients
- Diagnosed with Nocardia pneumonia (for the study group)
- Age ≥ 18 years
Who cannot join
- Patients with incomplete medical records
- Patients who survived ≤ 3 days after transplantation
- Patients lost to follow-up
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
Official title: 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.
Read the 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.
- Conditions
- Nocardia Infections, Lung Transplantation
- Being tested
- Antibiotic Treatment
- Keywords
- Nocardia;, Pulmonary Microbiota;, Retrospective Study;, Immunosuppression
- Medical subject headings
- Nocardia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic TreatmentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: January 2023 to August 2024
Secondary outcomes (1)
Correlation Between Pulmonary Microbiota and Clinical Outcomes
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.
Measured: January 2023 to August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2023
- Primary completion1 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nocardia InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhibin Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhibin Xu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594133
- Sponsor's protocol ID
- ES-2024-K144
- Acronym
- NocardiaLM
- Status last verified
- Nov 2024
- First submitted
- 10 Sep 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31227922Fatahi-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.
PubMed 29146497Restrepo 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.
PubMed 30817024Lebeaux 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.
PubMed 24272063Peleg 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.
PubMed 17443467
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal and Cross-sectional Analysis of Pulmonary Microbiota in Lung Transplant Recipients Infected With Nocardia: A Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT06594133
- Acronym / sponsor ID
- NocardiaLM / ES-2024-K144
- Conditions
- Nocardia Infections, Lung Transplantation
- Keywords
- Nocardia;, Pulmonary Microbiota;, Retrospective Study;, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Zhibin XuUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nocardia Pneumonia Group (NPG) | – | Drug: Antibiotic TreatmentThis 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Lung transplant recipients
- Diagnosed with Nocardia pneumonia (for the study group)
- Age ≥ 18 years
Key exclusion criteria (3 listed)
- Patients with incomplete medical records
- Patients who survived ≤ 3 days after transplantation
- Patients lost to follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic TreatmentFor 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. | Drug | Nocardia Pneumonia Group (NPG) |
Primary outcome
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.
1 secondary outcome
Correlation Between Pulmonary Microbiota and Clinical Outcomes
Time frame: January 2023 to August 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 31227922Hemmersbach-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.
- Results publication: PubMed 29146497Fatahi-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.
- Results publication: PubMed 30817024Restrepo 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.
- Results publication: PubMed 24272063Lebeaux 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.
- Results publication: PubMed 17443467Peleg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nocardia Infections and Lung Transplantation, run by Zhibin Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Microbiota Diversity in Nocardia-infected Lung Transplant Recipients (time frame: January 2023 to August 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594133, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.