Bronchoalveolar Lavage Combined With High-throughput Sequencing Technology

NCT07005466 | Completed

• 2 other identifiers: NFEC-2021-0192018CR019
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pneumonia

Keywords

Immunosuppressive Host control pneumonia; NGS; pneumonia; Checkpoint inhibitor related pneumonia; Pulmonary aspergillosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2021.01-2024.12

Secondary Outcomes (4)

• Therapeutic success rate

  2021.01-2024.12

• the proportion of cases in which an adverse event occurs.

  2021.01-2024.12

• the average length of stay of patients in the hospital.

  2021.01-2024.12

• Survival rate

  2021.01-2024.12

Study Arms (2)

Patients with lung infections

the positive of CMT or NGS

Patients without lung infections

the negative of CMT or NGS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• No paired conventional microbiological tests (smear，culture，etc.)；
• Incomplete case records；
• Inability to complete bronchoalveolar lavage (BAL)

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Guangdong Locations

Guangzhou, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Alveolar lavage fluid, venous blood and sputum were collected

MeSH Terms

Conditions

Pneumonia; Pulmonary Aspergillosis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Lung Diseases, Fungal

Study Officials

• Liu Laiyu, professor

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 5, 2025
• Study Start: January 20, 2019
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)