Prospective Study on the Efficacy and Safety of Bronchoalveolar Lavage Combined With Pathogen Metagenomic Sequencing Technology in the Diagnosis of Immune Checkpoint Inhibitor Associated Pneumonia

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Immune checkpoint inhibitor associated pneumonia (CIP) is a common immune related adverse reaction, accounting for 35% of all deaths. However, due to the lack of typical clinical symptoms and imaging manifestations, CIP needs to be differentiated from other diseases such as pulmonary infections and lung cancer progression. Currently, there is a lack of diagnostic gold standards, which belongs to exclusive diagnosis. Empirical diagnosis and treatment in clinical practice can easily lead to the abuse of hormones and antibiotics, and even misdiagnosis and mistreatment, resulting in patient death. Therefore, early identification of CIP and pulmonary infection is the key to successful diagnosis and treatment. The CIP diagnosis and treatment guidelines recommend performing bronchoalveolar lavage as appropriate, but there is still a lack of large-scale prospective clinical studies. The beneficial pathogen metagenomic sequencing technology for the diagnosis of pulmonary infections has not been mentioned. Our research group conducted a prospective clinical study for the first time to evaluate the effectiveness and safety of bronchoalveolar lavage combined with pathogen metagenomic sequencing technology in diagnosing CIP, explore biomarkers for diagnosing CIP, in order to improve the early diagnosis rate and treatment efficiency of CIP, and reduce the abuse of antibiotics and hormones.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
View:

• Voluntarily sign an informed consent form;

• Age range from 18 to 75 years old, regardless of gender;

• Immunosuppressive host;

• Symptoms, signs, or imaging signs of pneumonia are visible, and empirical anti infection treatment is ineffective.

Locations
Other Locations
China
Southern Medical University Nanfang Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Xintong Huang
1556807596@qq.com
8619355230761
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 104
Treatments
CIP cohort
non CIP cohort
Related Therapeutic Areas
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov