PneumoniaNCT07005466
Bronchoalveolar Lavage Combined With High-throughput Sequencing Technology
An observational study of Pneumonia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
High-throughput sequencing technology/Metagenomic next generation sequencing (mNGS) has extensive applications in fields such as whole-genome sequencing, transcriptome, gene expression regulation, and epigenetics. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pneumonia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2019to 30 Dec 2024
- How long will I take part?
- 3 Years
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who meet all of the following criteria are eligible to participate in the study: Sign the informed consent form voluntarily; Age 18-75 years old, no gender limitation; Immunosuppressive host; Symptoms, signs, or imaging of pneumonia show signs of pneumonia, and empiric anti-infection treatment is ineffective.
Who may be able to join
- Voluntary signing of informed consent;
- Age 14-75 years, No gender limitation；
- Immunosuppressed host；
- Symptoms，signs or imaging findings of pneumonia，and ineffective empirical anti-infection treatment；
- Specimens collected for NGS testing.
Who cannot join
- No paired conventional microbiological tests (smear，culture，etc.)；
- Incomplete case records；
- Inability to complete bronchoalveolar lavage (BAL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Bronchoalveolar Lavage Combined With High-throughput Sequencing Technology in the Precise Diagnosis of Immunosuppressive Host Pneumonia
High-throughput sequencing technology/Metagenomic next generation sequencing (mNGS) has extensive applications in fields such as whole-genome sequencing, transcriptome, gene expression regulation, and epigenetics. Because mNGS has the characteristics of large sequencing throughput, short time and high sensitivity, it can detect thousands of pathogens including bacteria, viruses, true bacteria and parasites, and is widely used in infectious diseases. In 2020, the "Expert Consensus on the Clinical Application of Metagenomic Second-Generation Sequencing Technology in Detecting Infectious Pathogens in China" proposed that for immunodeficient patients, mNGS can significantly increase the detection rate of pathogens and can be used as a first-line detection method. However, at present, there is no unified standard for the interpretation of mNGS results in the environment with bacteria in the respiratory tract, and there are not many studies on the efficacy of mNGS applied in the detection of bacteria and fungi. This study explored the clinical application value of mNGS in the pathogen detection of pneumonia in immunosuppressed hosts.
Read the detailed description
Infection is the most common complication in immunosuppressed hosts, and lung infection is one of the leading causes of hospitalization and death in immunosuppressed hosts, and accurate pathogenetic diagnosis of pneumonia in immunosuppressed hosts remains challenging at present. Bronchoalveolar lavage is the standard method for sampling microorganisms in the lower respiratory tract, and with the progressive application of high-throughput sequencing (NGS) technology for pathogenetic testing and its success, we have clinically observed that bronchoalveolar lavage combined with NGS improves the rate of pathogenic diagnosis of pneumonia in the immunosuppressed host and benefits the patient. In this project, we plan to prospectively enroll patients with immunosuppressed host pneumonia and perform both bronchoalveolar lavage NGS and clinical conventional sputum culture, blood culture, TB-DNA test, fungal GM test, viral PCR test and other pathogenicity tests, and based on the above results, we will explore whether bronchoalveolar lavage in combination with NGS can increase the rate of pathogenic diagnosis of immunosuppressed host pneumonia and evaluate the effectiveness of the clinical value of NGS in serving as a tool for pneumonia detection and control and in optimizing antibiotic treatment strategies for pneumonia in immunosuppressed hosts.
This study compared the positive rate and accuracy rate of pathogen detection in immunosuppressive host pneumonia by mNGS and CMT, and explored the clinical value of bronchoalveolar lavage combined with high-throughput sequencing technology in the precise diagnosis of immunosuppressive host pneumonia. To increase the etiological diagnosis rate of pneumonia in immunosuppressed hosts, shorten the diagnosis time and improve its prognosis.
- Conditions
- Pneumonia
- Keywords
- Immunosuppressive Host control pneumonia, NGS, pneumonia, Checkpoint inhibitor related pneumonia, Pulmonary aspergillosis
- Medical subject headings
- Pneumonia, Pulmonary Aspergillosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lung infections | the positive of CMT or NGS | |
| Patients without lung infections | the negative of CMT or NGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity in pneumonia patients
Sensitivity: the ratio of the number of positive cases detected within the experimental group diagnosed with the disease by the gold standard.
Specificity: the ratio of the number of negative cases detected in the control group diagnosed as disease-free by the gold standard.
Measured: 2021.01-2024.12
Positive predictive value (PPV), negative predictive value (NPV) in pneumonia patients
Positive predictive value: the proportion of positive diagnostic test results to be evaluated that are actually diseased, i.e., the percentage of positive results that are predictive of actual disease.
Negative predictive value: the proportion of cases that are positive for a given disease among the diagnostic tests to be evaluated, i.e., the percentage of cases that can be predicted to be truly diseased from the positive results.
Measured: 2021.01-2024.12
Secondary outcomes (4)
Therapeutic success rate
Therapeutic success rate: the proportion of cases in which the diagnostic test to be evaluated was positive that were successfully treated.
Measured: 2021.01-2024.12
the proportion of cases in which an adverse event occurs.
Safety: the proportion of cases in which an adverse event occurs.
Measured: 2021.01-2024.12
the average length of stay of patients in the hospital.
Mean length of stay: the average length of stay of patients in the hospital.
Measured: 2021.01-2024.12
Survival rate
Survival rate: the proportion of treated patients who are alive at 30, 60 and 90 days after the onset of illness.
Measured: 2021.01-2024.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start20 Jan 2019
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu Laiyu, professor, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005466
- Sponsor's protocol ID
- NFEC-2021-019
- Other IDs
- 2018CR019
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Bronchoalveolar Lavage Combined With High-throughput Sequencing Technology in the Precise Diagnosis of Immunosuppressive Host Pneumonia
- ClinicalTrials.gov ID
- NCT07005466
- Acronym / sponsor ID
- NFEC-2021-019
- Conditions
- Pneumonia
- Keywords
- Immunosuppressive Host control pneumonia, NGS, pneumonia, Checkpoint inhibitor related pneumonia, Pulmonary aspergillosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Jun 2025 (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.
High-throughput sequencing technology/Metagenomic next generation sequencing (mNGS) has extensive applications in fields such as whole-genome sequencing, transcriptome, gene expression regulation, and epigenetics. Because mNGS has the characteristics of large sequencing throughput, short time and high sensitivity, it can detect thousands of pathogens including bacteria, viruses, true bacteria and parasites, and is widely used in infectious diseases. In 2020, the "Expert Consensus on the Clinical Application of Metagenomic Second-Generation Sequencing Technology in Detecting Infectious Pathogens in China" proposed that for immunodeficient patients, mNGS can significantly increase the detection rate of pathogens and can be used as a first-line detection method. However, at present, there is no unified standard for the interpretation of mNGS results in the environment with bacteria in the respiratory tract, and there are not many studies on the efficacy of mNGS applied in the detection of bacteria and fungi. This study explored the clinical application value of mNGS in the pathogen detection of pneumonia in immunosuppressed hosts.
Detailed description
Infection is the most common complication in immunosuppressed hosts, and lung infection is one of the leading causes of hospitalization and death in immunosuppressed hosts, and accurate pathogenetic diagnosis of pneumonia in immunosuppressed hosts remains challenging at present. Bronchoalveolar lavage is the standard method for sampling microorganisms in the lower respiratory tract, and with the progressive application of high-throughput sequencing (NGS) technology for pathogenetic testing and its success, we have clinically observed that bronchoalveolar lavage combined with NGS improves the rate of pathogenic diagnosis of pneumonia in the immunosuppressed host and benefits the patient. In this project, we plan to prospectively enroll patients with immunosuppressed host pneumonia and perform both bronchoalveolar lavage NGS and clinical conventional sputum culture, blood culture, TB-DNA test, fungal GM test, viral PCR test and other pathogenicity tests, and based on the above results, we will explore whether bronchoalveolar lavage in combination with NGS can increase the rate of pathogenic diagnosis of immunosuppressed host pneumonia and evaluate the effectiveness of the clinical value of NGS in serving as a tool for pneumonia detection and control and in optimizing antibiotic treatment strategies for pneumonia in immunosuppressed hosts.
This study compared the positive rate and accuracy rate of pathogen detection in immunosuppressive host pneumonia by mNGS and CMT, and explored the clinical value of bronchoalveolar lavage combined with high-throughput sequencing technology in the precise diagnosis of immunosuppressive host pneumonia. To increase the etiological diagnosis rate of pneumonia in immunosuppressed hosts, shorten the diagnosis time and improve its prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with lung infections | – | –the positive of CMT or NGS |
| Patients without lung infections | – | –the negative of CMT or NGS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet all of the following criteria are eligible to participate in the study: Sign the informed consent form voluntarily; Age 18-75 years old, no gender limitation; Immunosuppressive host; Symptoms, signs, or imaging of pneumonia show signs of pneumonia, and empiric anti-infection treatment is ineffective.
Key inclusion criteria (5 listed)
- Voluntary signing of informed consent;
- Age 14-75 years, No gender limitation；
- Immunosuppressed host；
- Symptoms，signs or imaging findings of pneumonia，and ineffective empirical anti-infection treatment；
- Specimens collected for NGS testing.
Key exclusion criteria (3 listed)
- No paired conventional microbiological tests (smear，culture，etc.)；
- Incomplete case records；
- Inability to complete bronchoalveolar lavage (BAL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity, specificity in pneumonia patients
Time frame: 2021.01-2024.12
Sensitivity: the ratio of the number of positive cases detected within the experimental group diagnosed with the disease by the gold standard. Specificity: the ratio of the number of negative cases detected in the control group diagnosed as disease-free by the gold standard.
Positive predictive value (PPV), negative predictive value (NPV) in pneumonia patients
Time frame: 2021.01-2024.12
Positive predictive value: the proportion of positive diagnostic test results to be evaluated that are actually diseased, i.e., the percentage of positive results that are predictive of actual disease. Negative predictive value: the proportion of cases that are positive for a given disease among the diagnostic tests to be evaluated, i.e., the percentage of cases that can be predicted to be truly diseased from the positive results.
4 secondary outcomes
Therapeutic success rate
Time frame: 2021.01-2024.12
the proportion of cases in which an adverse event occurs.
Time frame: 2021.01-2024.12
the average length of stay of patients in the hospital.
Time frame: 2021.01-2024.12
Survival rate
Time frame: 2021.01-2024.12
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 5 Jun 2025.
- 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.
Liu Laiyu, professor study chair
Nanfang Hospital, Southern Medical University
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 Pneumonia, run by Nanfang Hospital, Southern Medical University 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 5 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 5 Jun 2025. 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?
Sensitivity, specificity in pneumonia patients (time frame: 2021.01-2024.12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.